JPA · Product Code · Chrysalis Intelligence

Device class

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Regulation —

Total clearances

2021-12-29 → 2026-04-27

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
Haemonetics Corporation	3	0	2025-04-30
Instrumentation Laboratory	2	0	2023-12-29
Diagnostica Stago S.A.S	1	0	2023-06-07
Diagnostica Stago, Inc.	1	1	2026-04-27
Accriva Diagnostics, Inc.	1	0	2021-12-29
Tem Innovations GmbH	1	0	2022-07-08
Sysmex America, Inc.	1	0	2025-06-02

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
85610	CPT	—	High	Prothrombin time (PT) multipurpose coagulation system/analyzer used for in vitro studies
85730	CPT	—	Medium	Thromboplastin time partial (aPTT) multipurpose coagulation testing alternative

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-04-27	K253658	Diagnostica Stago, Inc.	STA Satellite Max®
2025-06-02	K250965	Sysmex America, Inc.	Automated Blood Coagulation Analyzer CN-Series (CN-6000)
2025-04-30	K251024	Haemonetics	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
2025-01-15	K243858	Haemonetics Corporation	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
2024-03-29	K232018	Haemonetics Corporation	Citrated: K, KH, RTH, FFH
2023-12-29	K233790	Instrumentation Laboratory	ACL TOP 970 CL
2023-09-29	K221359	Instrumentation Laboratory CO	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
2023-06-07	K212183	Diagnostica Stago S.A.S	STA R Max 3, STA Compact Max 3
2022-07-08	K201440	Tem Innovations GmbH	ROTEM sigma Thromboelastometry System
2021-12-29	K202101	Accriva Diagnostics, Inc.	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2

JPA · Unclassified

Clearance volume by quarter

Top sponsors in this product code

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

Most recent 510(k) clearances