ELITECH GAMMA GT TEST KIT— 510(k) K901090

Name: FDA 510(k) clearance K901090
Creator: U.S. Food and Drug Administration
Published: 1990-03-29

Substantially Equivalent

Elite Technology, Inc.

FDA 510(k) clearance K901090 for ELITECH GAMMA GT TEST KIT, Substantially Equivalent on 1990-03-29. Applicant: Elite Technology, Inc.. Device class: 1.

Clearance details

Applicant: Elite Technology, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 1990-03-07
Decision date: 1990-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Canada M9w 5p1, CA

Download summary PDF View on FDA.gov ↗

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K020486 — CARESIDE GGT2002-07-01
K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE1996-07-01
K923509 — GAMMA-GT1992-12-03
K923091 — KING DIAGNOSTICS GAMMA GT REAGENT1992-09-09
K905618 — GGT REAGENT1991-02-26

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Data sourced from openFDA. This site is unofficial and independent of the FDA.