Cleared Traditional

K811576 - CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)
(FDA 510(k) Clearance)

K811576 · Harleco · Chemistry

Jun 1981

Decision

21d

Days

Class 2

Risk

K811576 is an FDA 510(k) clearance for the CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A). This device is classified as 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 June 25, 1981, 21 days after receiving the submission on June 4, 1981.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K811576 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 1981
Decision Date	June 25, 1981
Days to Decision	21 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—