COAGUCHEK S SYSTEM, MODEL 2138280— 510(k) K994349

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K994349 for COAGUCHEK S SYSTEM, MODEL 2138280, Substantially Equivalent on 2000-09-06. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1999-12-23
Decision date: 2000-09-06
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.