Cleared Traditional

SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)

K971466 · Carolina Liquid Chemistries Corp. · Chemistry
May 1997
Decision
14d
Days
Class 1
Risk

About This 510(k) Submission

K971466 is an FDA 510(k) clearance for the SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT), a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on May 6, 1997, 14 days after receiving the submission on April 22, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K971466 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1997
Decision Date May 06, 1997
Days to Decision 14 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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