GAMMA STIK 125I T3 UPTAKE KIT— 510(k) K780492

Substantially Equivalent

Alpha Gamma Laboratory

FDA 510(k) clearance K780492 for GAMMA STIK 125I T3 UPTAKE KIT, Substantially Equivalent on 1978-04-28. Applicant: Alpha Gamma Laboratory.

Clearance details

Applicant: Alpha Gamma Laboratory
Product code: Code CDP
Advisory panel: Clinical Chemistry
Date received: 1978-03-27
Decision date: 1978-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CDP

product code CDP

Malfunction: 647
Total: 647

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.