Cleared Traditional

K812593 - ULTRA ZYME PLUS CK-1 #64978, 65027 & 28
(FDA 510(k) Clearance)

K812593 · Harleco · Chemistry

Oct 1981

Decision

21d

Days

Class 2

Risk

K812593 is an FDA 510(k) clearance for the ULTRA ZYME PLUS CK-1 #64978, 65027 & 28, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Harleco (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981, 21 days after receiving the submission on September 11, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K812593 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 11, 1981
Decision Date	October 02, 1981
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—