GAMMA-GLUTAMYL TRANSPEPTIDASE— 510(k) K964916

Name: FDA 510(k) clearance K964916
Creator: U.S. Food and Drug Administration
Published: 1997-01-10

Substantially Equivalent

Derma Media Lab., Inc.

FDA 510(k) clearance K964916 for GAMMA-GLUTAMYL TRANSPEPTIDASE, Substantially Equivalent on 1997-01-10. Applicant: Derma Media Lab., Inc.. Device class: 1.

Clearance details

Applicant: Derma Media Lab., Inc.
Product code: Code JQB
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1996-12-09
Decision date: 1997-01-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Fe Springs, CA, US

Download summary PDF View on FDA.gov ↗

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