GAMMA STICK 125-1 TOBRAMYCIN RIA KIT— 510(k) K810011

Name: FDA 510(k) clearance K810011
Creator: U.S. Food and Drug Administration
Published: 1981-01-28

Substantially Equivalent

Alpha Gamma Laboratory

FDA 510(k) clearance K810011 for GAMMA STICK 125-1 TOBRAMYCIN RIA KIT, Substantially Equivalent on 1981-01-28. Applicant: Alpha Gamma Laboratory. Device class: 2.

Clearance details

Applicant: Alpha Gamma Laboratory
Product code: Code KLB
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1981-01-05
Decision date: 1981-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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