Cleared Traditional

K812591 - ULTRA ZYME PLUS GPT, #64956, 65035 & 36
(FDA 510(k) Clearance)

K812591 · Harleco · Chemistry

Sep 1981

Decision

13d

Days

Class 1

Risk

K812591 is an FDA 510(k) clearance for the ULTRA ZYME PLUS GPT, #64956, 65035 & 36. This device is classified as a Nadh Oxidation/nad Reduction, Alt/sgpt (Class I — General Controls, product code CKA).

Submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on September 24, 1981, 13 days after receiving the submission on September 11, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number	K812591 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1981
Decision Date	September 24, 1981
Days to Decision	13 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—