Cleared Traditional

CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER

K062737 · Horiba Abx · Chemistry
Jun 2007
Decision
272d
Days
Class 2
Risk

About This 510(k) Submission

K062737 is an FDA 510(k) clearance for the CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Horiba Abx (Montpellier, FR). The FDA issued a Cleared decision on June 12, 2007, 272 days after receiving the submission on September 13, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K062737 FDA.gov
FDA Decision Cleared SESE
Date Received September 13, 2006
Decision Date June 12, 2007
Days to Decision 272 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGS — Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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