GAMMA GLUTAMYLTRANSFERASE REAGENT— 510(k) K871979

Name: FDA 510(k) clearance K871979
Creator: U.S. Food and Drug Administration
Published: 1987-06-11

Substantially Equivalent

Intersect Systems, Inc.

FDA 510(k) clearance K871979 for GAMMA GLUTAMYLTRANSFERASE REAGENT, Substantially Equivalent on 1987-06-11. Applicant: Intersect Systems, Inc.. Device class: 1.

Clearance details

Applicant: Intersect Systems, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1987-05-22
Decision date: 1987-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longview, WA, US

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