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

Name: FDA 510(k) clearance K780492
Creator: U.S. Food and Drug Administration
Published: 1978-04-28

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. Device class: 2.

Clearance details

Applicant: Alpha Gamma Laboratory
Product code: Code CDP
Device class: Class 2
Regulation: 21 CFR 862.1710
Advisory panel: Clinical Chemistry
Date received: 1978-03-27
Decision date: 1978-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K991252 — AIA-PACK FT3 ASSAY1999-05-11
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More clearances from Alpha Gamma Laboratory

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K810011 — GAMMA STICK 125-1 TOBRAMYCIN RIA KIT1981-01-28
K800537 — GAMMA STICK GENTAMICIN RIA KIT1980-04-24
K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT1980-04-24

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.