Cleared Traditional

GAMMA-GLUTAMYL TRANSFERASE DETERMINATION

K905649 · Biochemical Trade, Inc. · Chemistry
Jan 1991
Decision
43d
Days
Class 1
Risk

About This 510(k) Submission

K905649 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSFERASE DETERMINATION, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Biochemical Trade, Inc. (Miami, US). The FDA issued a Cleared decision on January 30, 1991, 43 days after receiving the submission on December 18, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K905649 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1990
Decision Date January 30, 1991
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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