Cleared Traditional

GAMMA-GLUTAMYL TRANSPEPTIDASE

K964916 · Derma Media Lab., Inc. · Chemistry
Jan 1997
Decision
32d
Days
Class 1
Risk

About This 510(k) Submission

K964916 is an FDA 510(k) clearance for the GAMMA-GLUTAMYL TRANSPEPTIDASE, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Derma Media Lab., Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on January 10, 1997, 32 days after receiving the submission on December 9, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K964916 FDA.gov
FDA Decision Cleared SESE
Date Received December 09, 1996
Decision Date January 10, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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