GKZ · Product Code · Chrysalis Intelligence

Device class

—

Regulation —

Total clearances

2020-04-16 → 2026-05-27

Last 12 months

Unique sponsors

Classification details

Medical specialty

—

Review panel

—

Regulation number

—

Implant

—

Life-sustain / support

—

GMP exempt

—

Third-party review

—

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
Beckman Coulter	2	0	2024-07-05
Athelas, Inc.	2	1	2026-02-06
Pixcell Medical Technologies, Ltd.	2	0	2024-05-02
HORIBA ABX SAS	1	0	2024-05-21
Ad Astra Diagnostics, Inc.	1	0	2023-11-14
Cytochip, Inc.	1	0	2025-02-03
S.D. Sight Diagnostics , Ltd.	1	0	2022-05-09
Truvian Sciences, Inc.	1	1	2026-01-16

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
85025	CPT	—	High	CPT code for complete blood count (CBC) with differential cell count using automated analyzer

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
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

GKZ · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances