GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A— 510(k) K030555

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K030555 for GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A, Substantially Equivalent on 2003-04-11. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JQC
Advisory panel: Clinical Chemistry
Date received: 2003-02-21
Decision date: 2003-04-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code JQC

product code JQC

Other: 1
Total: 1

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.