CGA · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2020-02-07 → 2026-05-01

Last 12 months

Unique sponsors

Classification details

Medical specialty

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Review panel

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Regulation number

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Implant

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Life-sustain / support

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GMP exempt

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Third-party review

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Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Abbott Point of Care, Inc.	4	0	2023-09-11
Nova Biomedical Corporation	2	0	2022-10-18
Ysi, Inc.	1	0	2024-09-30
Medica Corporation	1	0	2024-07-26
Alere San Diego, Inc.	1	0	2023-09-20
Radiometer Medicals Aps	1	1	2026-05-01
Instrumentation Laboratory CO	1	0	2023-01-27

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.

Code	Type	Description	Confidence	Rationale
82945	CPT	—	High	Standard CPT for glucose oxidase method (alternative glucose assay)

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-01	K252488	Radiometer Medicals Aps	ABL90 FLEX PLUS System
2024-09-30	K210933	Ysi, Inc.	YSI 2900C Biochemistry Analyzer
2024-07-26	K220328	Medica Corporation	EasyStat 300
2023-09-20	K223179	Alere San Diego, Inc.	Cholestech LDX System
2023-09-11	K223755	Abbott Point of Care, Inc.	i-STAT G cartridge with the i-STAT 1 System
2023-07-28	K223710	Abbott Point of Care, Inc.	i-STAT CG8+ cartridge with the i-STAT 1 System
2023-01-27	K223090	Instrumentation Laboratory CO	GEM Premier ChemSTAT
2022-10-18	K203549	Nova Biomedical Corporation	Nova Primary Glucose Analyzer System
2021-08-13	K210958	Abbott Point of Care, Inc.	i-STAT CHEM8+ cartridge with the i-STAT 1 System
2020-03-13	K200349	Nova Biomedical Corporation	Stat Profile Prime Plus Analyzer System
2020-02-07	K183678	Abbott Point of Care, Inc.	i-STAT CHEM8+ cartridge with the i-STAT 1 System

CGA · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances