Cleared Traditional

OLYMPUS CK-MB REAGENT

K070835 · Olympus Life & Material Science Europa GmbH (Irish · Chemistry
Jun 2007
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K070835 is an FDA 510(k) clearance for the OLYMPUS CK-MB REAGENT, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Olympus Life & Material Science Europa GmbH (Irish (O'Callaghans Mills, Co. Clare, IE). The FDA issued a Cleared decision on June 4, 2007, 69 days after receiving the submission on March 27, 2007. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K070835 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2007
Decision Date June 04, 2007
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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