BLOOD CELL SEPARATOR 2997— 510(k) K771258

Substantially Equivalent

Intl. Business Machines

FDA 510(k) clearance K771258 for BLOOD CELL SEPARATOR 2997, Substantially Equivalent on 1977-09-06. Applicant: Intl. Business Machines.

Clearance details

Applicant: Intl. Business Machines
Product code: Code GKT
Advisory panel: Hematology
Date received: 1977-07-12
Decision date: 1977-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.