KOAGULAB* M COAGULATION SYSTEM— 510(k) K862537

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K862537 for KOAGULAB* M COAGULATION SYSTEM, Substantially Equivalent on 1986-07-21. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1986-07-02
Decision date: 1986-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raritan, NJ, 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.