Cleared Traditional

ULTRA ZYME PLUS GAMMA GT #65055 & 56

K830308 · Emd Chemicals, Inc. · Chemistry
Feb 1983
Decision
28d
Days
Class 1
Risk

About This 510(k) Submission

K830308 is an FDA 510(k) clearance for the ULTRA ZYME PLUS GAMMA GT #65055 & 56, a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Emd Chemicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 28, 1983, 28 days after receiving the submission on January 31, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K830308 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 1983
Decision Date February 28, 1983
Days to Decision 28 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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