KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS— 510(k) K853328

Substantially Equivalent

Ortho Diagnostic Systems, Inc.

FDA 510(k) clearance K853328 for KOAGULAB 16-S SEMI-AUTOMATED COAGULATION SYS, Substantially Equivalent on 1985-11-05. Applicant: Ortho Diagnostic Systems, Inc..

Clearance details

Applicant: Ortho Diagnostic Systems, Inc.
Product code: Code JPA
Advisory panel: Hematology
Date received: 1985-08-08
Decision date: 1985-11-05
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.