Cleared Traditional

GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM

K955770 · Abaxis, Inc. · Chemistry
Sep 1996
Decision
263d
Days
Class 1
Risk

About This 510(k) Submission

K955770 is an FDA 510(k) clearance for the GAMMA GLUTAMYL TRANSFERASE TEST SYSTEM, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Abaxis, Inc. (Sunnyvale, US). The FDA issued a Cleared decision on September 9, 1996, 263 days after receiving the submission on December 21, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K955770 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1995
Decision Date September 09, 1996
Days to Decision 263 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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