COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN— 510(k) K900377

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K900377 for COLLEGE OF AMER PATH. REFER. PREP. FOR FIBRINOGEN, Substantially Equivalent on 1990-03-06. Applicant: Baxter Healthcare Corp.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code JPA
Advisory panel: Hematology
Date received: 1990-01-26
Decision date: 1990-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, 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.