PREZAPAK L ARTERIAL BLOOD SAMPLING KIT— 510(k) K801015

Substantially Equivalent

Kimble-Terumo, Inc.

FDA 510(k) clearance K801015 for PREZAPAK L ARTERIAL BLOOD SAMPLING KIT, Substantially Equivalent on 1980-05-14. Applicant: Kimble-Terumo, Inc..

Clearance details

Applicant: Kimble-Terumo, Inc.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 1980-04-29
Decision date: 1980-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code GIM

product code GIM

Malfunction: 1,325
Total: 1,325

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.