AUTOMATED 8400 BLOOD CELL SEPARATOR— 510(k) K831004

Substantially Equivalent

Intl. Business Machines

FDA 510(k) clearance K831004 for AUTOMATED 8400 BLOOD CELL SEPARATOR, Substantially Equivalent on 1983-09-12. Applicant: Intl. Business Machines.

Clearance details

Applicant: Intl. Business Machines
Product code: Code LKN
Advisory panel: Unknown
Date received: 1983-03-29
Decision date: 1983-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LKN

product code LKN

Death: 50
Injury: 314
Total: 364

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.