Coaguchek System, Coaguchek System for Prothrombin Time Self Testing

Q: What is the product code of K974569?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.

FDA 510(k) K974569 · Boehringer Mannheim Corp.

Substantially Equivalent

510(k) numberK974569

Submission

Device name: Coaguchek System, Coaguchek System for Prothrombin Time Self Testing
Applicant: Boehringer Mannheim Corp.
Indianapolis, IN, US
Received: December 8, 1997
Decision date: January 9, 1998
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: JPA – System, Multipurpose For In Vitro Coagulation Studies
Device class: Class II (moderate risk)
Regulation: 21 CFR 864.5425
Specialty: Hematology

Other 510(k)s with product code JPA

510(k)	Device	Applicant	Decision
K253658	STA Satellite Max®JPA · Traditional	Diagnostica Stago, Inc.	04/27/2026SE
K250965	Automated Blood Coagulation Analyzer CN-Series (CN-6000)JPA · Traditional	Sysmex America, Inc.	06/02/2025SE
K251024	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special	Haemonetics	04/30/2025SE
K243858	TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay CartridgeJPA · Special	Haemonetics Corporation	01/15/2025SE
K232018	Citrated: K, KH, RTH, FFHJPA · Traditional	Haemonetics Corporation	03/29/2024SE
K233790	Acl Top 970 CLJPA · Special	Instrumentation Laboratory	12/29/2023SE
K221359	ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional	Instrumentation Laboratory CO	09/29/2023SE
K212183	STA R Max 3, STA Compact Max 3JPA · Traditional	Diagnostica Stago S.A.S	06/07/2023SE
K201440	ROTEM sigma Thromboelastometry SystemJPA · Traditional	Tem Innovations GmbH	07/08/2022SE
K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+)…JPA · Traditional	Accriva Diagnostics, Inc.	12/29/2021SE

More from Accriva Diagnostics, Inc.

510(k)	Device	Decision
K984326	Elecys Ige AssayJHR · Traditional	02/08/1999SE
K983047	Accu-Chek HQ SystemLFR · Traditional	02/05/1999SE
K984419	Elecsys Ige CalcheckJJY · Traditional	02/02/1999SE
K984425	Modification of Preciset Serum Proteins CalibratorJIX · Traditional	01/20/1999SE
K984372	Elecsys Calcheck Troponin TJJY · Traditional	12/14/1998SE
K984105	Elecsys Troponin T Stat TestMMI · Traditional	12/08/1998SE
K983503	Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional	12/01/1998SE
K983469	Preciset Serum Proteins CalibratorJIX · Traditional	11/25/1998SE
K983185	Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional	11/12/1998SE
K983510	Chemstrip 101 Urine AnalyzerKQO · Special	10/27/1998SE

Questions and answers

When was Coaguchek System, Coaguchek System for Prothrombin Time Self Testing cleared by the FDA?

Coaguchek System, Coaguchek System for Prothrombin Time Self Testing (K974569) received a 510(k) decision of Substantially Equivalent on January 9, 1998, 32 days after the submission was received.

What is the product code of K974569?

The FDA product code is JPA – System, Multipurpose For In Vitro Coagulation Studies, a Class II (moderate risk) device regulated under 21 CFR 864.5425.