GAMMA GLUTAMYL TRANSFERASE REAGENT SET— 510(k) K881239

Name: FDA 510(k) clearance K881239
Creator: U.S. Food and Drug Administration
Published: 1988-05-31

Substantially Equivalent

Tech-Neal Scientific, Inc.

FDA 510(k) clearance K881239 for GAMMA GLUTAMYL TRANSFERASE REAGENT SET, Substantially Equivalent on 1988-05-31. Applicant: Tech-Neal Scientific, Inc.. Device class: 1.

Clearance details

Applicant: Tech-Neal Scientific, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1988-03-22
Decision date: 1988-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chicago, IL, US

Download summary PDF View on FDA.gov ↗

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