AUTOMATED BLOOD CELL SEPARATOR— 510(k) K822521

Substantially Equivalent

Cryosan, Inc.

FDA 510(k) clearance K822521 for AUTOMATED BLOOD CELL SEPARATOR, Substantially Equivalent on 1982-09-30. Applicant: Cryosan, Inc..

Clearance details

Applicant: Cryosan, Inc.
Product code: Code GKT
Advisory panel: Hematology
Date received: 1982-08-23
Decision date: 1982-09-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code GKT

product code GKT

Death: 167
Injury: 301
Malfunction: 2,086
Total: 2,554

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.