THROMBOPLASTIN - FS— 510(k) K833272

Substantially Equivalent

American Dade

FDA 510(k) clearance K833272 for THROMBOPLASTIN - FS, Substantially Equivalent on 1983-11-03. Applicant: American Dade.

Clearance details

Applicant: American Dade
Product code: Code JPA
Advisory panel: Hematology
Date received: 1983-09-21
Decision date: 1983-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.