GAMMA STICK GENTAMICIN RIA KIT— 510(k) K800537

Name: FDA 510(k) clearance K800537
Creator: U.S. Food and Drug Administration
Published: 1980-04-24

Substantially Equivalent

Alpha Gamma Laboratory

FDA 510(k) clearance K800537 for GAMMA STICK GENTAMICIN RIA KIT, Substantially Equivalent on 1980-04-24. Applicant: Alpha Gamma Laboratory. Device class: 2.

Clearance details

Applicant: Alpha Gamma Laboratory
Product code: Code DJB
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 1980-03-10
Decision date: 1980-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K811844 — COAT-A-COUNT GENTAMICIN RIA KIT1981-07-10

More clearances from Alpha Gamma Laboratory

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K800538 — GAMMA STICK CORTISOL RIA KIT/STICK KIT1980-04-24
K780492 — GAMMA STIK 125I T3 UPTAKE KIT1978-04-28

Data sourced from openFDA. This site is unofficial and independent of the FDA.