COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING— 510(k) K974569

Substantially Equivalent

Boehringer Mannheim Corp.

FDA 510(k) clearance K974569 for COAGUCHEK SYSTEM, COAGUCHEK SYSTEM FOR PROTHROMBIN TIME SELF TESTING, Substantially Equivalent on 1998-01-09. Applicant: Boehringer Mannheim Corp..

Clearance details

Applicant: Boehringer Mannheim Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1997-12-08
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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Adverse events under product code JPA

product code JPA

Death: 6
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.