Cleared Traditional

RAICHEM GGT REAGENT

K905085 · Reagents Applications, Inc. · Chemistry
Dec 1990
Decision
36d
Days
Class 1
Risk

About This 510(k) Submission

K905085 is an FDA 510(k) clearance for the RAICHEM GGT REAGENT, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 1990, 36 days after receiving the submission on November 14, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K905085 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1990
Decision Date December 20, 1990
Days to Decision 36 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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