Cleared Traditional

ULTRAZYME PLUS GAMMA GT(65055-65056)

K820233 · Harleco · Chemistry
Feb 1982
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K820233 is an FDA 510(k) clearance for the ULTRAZYME PLUS GAMMA GT(65055-65056), a Kinetic Method, Gamma-glutamyl Transpeptidase (Class I — General Controls, product code JQB), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on February 12, 1982, 15 days after receiving the submission on January 28, 1982. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K820233 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1982
Decision Date February 12, 1982
Days to Decision 15 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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