PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM— 510(k) K021927

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K021927 for PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM, Substantially Equivalent on 2002-07-12. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code LXG
Advisory panel: Clinical Chemistry
Date received: 2002-06-12
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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Adverse events under product code LXG

product code LXG

Malfunction: 1,310
Total: 1,310

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.