GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT— 510(k) K822944

Name: FDA 510(k) clearance K822944
Creator: U.S. Food and Drug Administration
Published: 1982-12-30

Substantially Equivalent

Travenol Laboratories, S.A.

FDA 510(k) clearance K822944 for GAMMA DAB[125I]PTH RADIOIMMUNOASSAY KIT, Substantially Equivalent on 1982-12-30. Applicant: Travenol Laboratories, S.A.. Device class: 2.

Clearance details

Applicant: Travenol Laboratories, S.A.
Product code: Code CEW
Device class: Class 2
Regulation: 21 CFR 862.1545
Advisory panel: Clinical Chemistry
Date received: 1982-10-04
Decision date: 1982-12-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code CEW

product code CEW

Malfunction: 480
Total: 480

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.