Cleared Traditional

ELITECH GAMMA GT TEST KIT

K901090 · Elite Technology, Inc. · Chemistry
Mar 1990
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K901090 is an FDA 510(k) clearance for the ELITECH GAMMA GT TEST KIT, a Colorimetric Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JPZ), submitted by Elite Technology, Inc. (Canada M9w 5p1, CA). The FDA issued a Cleared decision on March 29, 1990, 22 days after receiving the submission on March 7, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K901090 FDA.gov
FDA Decision Cleared SESE
Date Received March 07, 1990
Decision Date March 29, 1990
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code JPZ — Colorimetric Method, Gamma-glutamyl Transpeptidase
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1360

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