KING DIAGNOSTICS GAMMA GT REAGENT— 510(k) K923091

Name: FDA 510(k) clearance K923091
Creator: U.S. Food and Drug Administration
Published: 1992-09-09

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K923091 for KING DIAGNOSTICS GAMMA GT REAGENT, Substantially Equivalent on 1992-09-09. Applicant: King Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1992-06-25
Decision date: 1992-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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