Chrysalis Intelligence · Product Codes · GKZ

GKZ · Counter, Differential Cell

Hematology · 19 clearances · 10 unique sponsors

← Library Overview New Filings 510(k) Explorer Recalls Explorer All Sponsors All Product Codes Orphan Products Signals
Device class
Class II
Regulation 864.5220
Total clearances
19
2020-04-16 → 2026-09-14
Last 12 months
4
Unique sponsors
10
Classification details
Medical specialty
Hematology
Review panel
HE
Regulation number
864.5220
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
Sysmex America, Inc. 5 1 2026-05-27
Abbott Laboratories 2 0 2025-02-20
Athelas, Inc. 2 1 2026-02-06
HORIBA ABX SAS 2 1 2026-09-14
Pixcell Medical Technologies, Ltd. 2 0 2024-05-02
Beckman Coulter 2 0 2024-07-05
Ad Astra Diagnostics, Inc. 1 0 2023-11-14
Truvian Sciences, Inc. 1 1 2026-01-16
S.D. Sight Diagnostics , Ltd. 1 0 2022-05-09
Cytochip, Inc. 1 0 2025-02-03
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
85025 CPT — High CPT code for complete blood count (CBC) with differential cell count using automated analyzer
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-09-14 K260781 HORIBA ABX SAS Yumizen H550
2026-05-27 K253212 Sysmex America, Inc. XR-Series (XR-10, XR-20) Automated Hematology Analyzers
2026-02-06 K243348 Athelas, Inc. Athelas Home
2026-01-16 K251249 Truvian Sciences, Inc. Tru Hematology Test
2025-06-25 K251371 Sysmex America, Inc. Sysmex XR-Series (XR-20) Automated Hematology Analyzer
2025-06-25 K250943 Sysmex America, Inc. Sysmex XR-Series (XR-10) Automated Hematology Analyzer
2025-02-20 K243283 Abbott Laboratories Alinity h-series System
2025-02-03 K240402 Cytochip, Inc. Cito CBC System
2024-07-05 K240252 Beckman Coulter, Inc. UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
2024-05-21 K232946 HORIBA ABX SAS Yumizen H2500
2024-05-02 K240636 Pixcell Medical Technologies HemoScreen Hematology Analyzer
2023-12-21 K230887 Sysmex America, Inc. Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
2023-11-14 K230878 Ad Astra Diagnostics, Inc. QScout Lab; QScout RLD
2023-08-16 K222148 Pixcell Medical Technologies, Ltd. HemoScreen Hematology Analyzer
2023-08-04 K220031 Abbott Laboratories Alinity h-series System
2022-11-08 K210346 Sysmex America, Inc. Sysmex XW-100 Automated Hematology Analyzer
2022-05-09 K211840 S.D. Sight Diagnostics , Ltd. Sight OLO
2022-03-22 K200828 Athelas, Inc. Athelas Home
2020-04-16 K193124 Beckman Coulter Unicel DxH 800 Coulter Cellular Analysis System
Data source: openFDA · Generated 2026-10-08 10:51 · Last ingest 2026-10-08T14:51:39.242493 · Pipeline: Chrysalis Intelligence