GAMMA-GT— 510(k) K923509

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K923509 for GAMMA-GT, Substantially Equivalent on 1992-12-03. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1992-07-15
Decision date: 1992-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

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