GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET— 510(k) K860348

Name: FDA 510(k) clearance K860348
Creator: U.S. Food and Drug Administration
Published: 1986-03-17

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860348 for GAMMA GLUTAMYL TRANSPEPTIDASE (GGTP) REAGENT SET, Substantially Equivalent on 1986-03-17. Applicant: Sterling Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1986-01-30
Decision date: 1986-03-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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