ASSAY FOR GAMMA GLUTAMYLTRANSFERASE— 510(k) K760346

Name: FDA 510(k) clearance K760346
Creator: U.S. Food and Drug Administration
Published: 1976-10-27

Substantially Equivalent

Princeton Biomedix

FDA 510(k) clearance K760346 for ASSAY FOR GAMMA GLUTAMYLTRANSFERASE, Substantially Equivalent on 1976-10-27. Applicant: Princeton Biomedix. Device class: 1.

Clearance details

Applicant: Princeton Biomedix
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1976-08-02
Decision date: 1976-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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