Cleared Traditional

ULTRAZYME-GT, ITEM #64959 & 65032

K813041 · Harleco · Chemistry
Nov 1981
Decision
13d
Days
Class 1
Risk

About This 510(k) Submission

K813041 is an FDA 510(k) clearance for the ULTRAZYME-GT, ITEM #64959 & 65032, 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 November 10, 1981, 13 days after receiving the submission on October 28, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1360.

Submission Details

510(k) Number K813041 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1981
Decision Date November 10, 1981
Days to Decision 13 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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