Chrysalis Intelligence · Product Codes · NBW

NBW · System, Test, Blood Glucose, Over The Counter

Clinical Chemistry · 41 clearances · 24 unique sponsors

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Device class
Class II
Regulation 862.1345
Total clearances
41
2020-01-17 → 2026-07-23
Last 12 months
2
Unique sponsors
24
Classification details
Medical specialty
Clinical Chemistry
Review panel
CH
Regulation number
862.1345
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Apex BioTechnology Corp. 7 0 2022-12-21
I-Sens, Inc. 4 0 2023-08-10
Ascensia Diabetes Care 3 0 2024-02-23
Roche Diabetes Care, Inc. 2 0 2023-08-10
Bionime Corporation 2 0 2024-11-04
Vivachek Biotech (Hangzhou) Co., Ltd. 2 0 2024-08-16
Bioland Technology, Ltd. 2 0 2022-08-12
Osang Healthcare Co. , Ltd. 2 0 2021-07-13
Ascensia Diabetes Care U.S., Inc. 2 0 2024-08-27
Sinocare, Inc. 1 0 2023-12-01
Polymer Technology Systems, Inc. D/B/A Pts Diagnostics 1 0 2022-02-26
Eps Bio Technology Corp. 1 0 2021-09-01
Mio Labs, Inc. 1 0 2023-06-28
Sejoy Biomedical Co., Ltd. 1 0 2024-10-08
Ok Biotech Co., Ltd. 1 0 2022-10-07
Agamatrix 1 0 2024-06-06
Microtech Medical, Inc. 1 0 2020-09-11
Guangdong Transtek Medical Electronics Co., Ltd. 1 0 2025-01-30
ACON Laboratories, Inc. 1 1 2025-10-10
Lifescan Europe GmbH 1 0 2020-02-14
Trividia Health, Inc. 1 1 2026-07-23
Taidoc Technology Corporation 1 0 2022-06-16
Hmd Biomedical, Inc. 1 0 2022-08-29
Livongo Health, Inc. 1 0 2020-06-04
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
82962 CPT — High Glucose, blood or whole blood, home testing device
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-07-23 K262116 Trividia Health, Inc. TRUE METRIX Self Monitoring Blood Glucose System
2025-10-10 K250085 ACON Laboratories, Inc. On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System
2025-01-30 K243060 Guangdong Transtek Medical Electronics Co., Ltd. TeleRPM Gen2 Blood Glucose Monitoring System
2024-11-04 K240637 Bionime Corporation RIGHTEST Blood Glucose Monitoring System Max Tel
2024-10-08 K240640 Sejoy Biomedical Co., Ltd. Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System
2024-08-27 K241787 Ascensia Diabetes Care U.S., Inc. CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System
2024-08-16 K222126 Vivachek Biotech (Hangzhou) Co., Ltd. VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System
2024-06-06 K241304 Agamatrix WaveSense Jazz Blood Glucose Monitoring System
2024-02-23 K231679 Ascensia Diabetes Care CONTOUR® PLUS BLUE Blood Glucose Monitoring System
2024-01-19 K231192 Bionime Corporation RIGHTEST Blood Glucose Monitoring System Max Tel
2023-12-22 K233058 Vivachek Biotech (Hangzhou) Co., Ltd. VivaChek Link Plus Blood Glucose Monitoring System
2023-12-01 K231476 Sinocare, Inc. TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System
2023-08-10 K230625 I-Sens, Inc. ReliOn Premier BLU Blood Glucose Monitoring System
2023-08-10 K213131 Roche Diabetes Care GmbH Accu-Chek Guide Solo diabetes manager blood glucose monitoring system
2023-06-28 K223722 Mio Labs, Inc. MIO Blood Glucose Monitoring System
2022-12-21 K222234 Apex BioTechnology Corp. GlucoSure ADVANCE Link Blood Glucose Monitoring System
2022-11-18 K223293 Ascensia Diabetes Care U.S., Inc. CONTOUR® NEXT GEN Blood Glucose Monitoring System
2022-11-04 K220421 Apex BioTechnology Corp. BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System
2022-10-07 K213061 Ok Biotech Co., Ltd. SuperCheck Pro Blood Glucose Monitoring System
2022-08-29 K212248 Hmd Biomedical, Inc. GlucoLeader Enhance 2 Blood Glucose Monitoring System
2022-08-25 K212140 Apex BioTechnology Corp. GlucoSure Link Blood Glucose Monitoring System
2022-08-12 K202739 Bioland Technology, Ltd. Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose Monitoring System
2022-06-16 K201037 Taidoc Technology Corporation FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring System
2022-05-06 K203711 Roche Diabetes Care, Inc. IWL2020 Blood Glucose Monitoring System
2022-04-06 K202534 Apex BioTechnology Corp. MTM301 Blood Glucose and Ketone Monitoring System
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence