Cleared Traditional

K012474: ATAC PAK CPK REAGENT KIT

K012474 · Elan Holdings, Inc. · Chemistry

Oct 2001

Decision

62d

Days

Class 2

Risk

About This 510(k) Submission

K012474 is an FDA 510(k) clearance for the ATAC PAK CPK REAGENT KIT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Elan Holdings, Inc. (Brea, US). The FDA issued a Cleared decision on October 3, 2001, 62 days after receiving the submission on August 2, 2001. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number	K012474 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 02, 2001
Decision Date	October 03, 2001
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF