BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT— 510(k) K933939

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K933939 for BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT, Substantially Equivalent on 1994-02-07. Applicant: Organon Teknika Corp..

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code GIM
Advisory panel: Clinical Chemistry
Date received: 1993-08-12
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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.