GLUTAMYLTRANSFERASE ASSAY KIT— 510(k) K850788

Name: FDA 510(k) clearance K850788
Creator: U.S. Food and Drug Administration
Published: 1985-03-19

Substantially Equivalent

Diagnostic Chemicals, Ltd. (Usa)

FDA 510(k) clearance K850788 for GLUTAMYLTRANSFERASE ASSAY KIT, Substantially Equivalent on 1985-03-19. Applicant: Diagnostic Chemicals, Ltd. (Usa). Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals, Ltd. (Usa)
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1985-02-26
Decision date: 1985-03-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada, CA

Download summary PDF View on FDA.gov ↗

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