Cleared Traditional

RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

K123977 · Randox Laboratories, Ltd. · Chemistry
Nov 2013
Decision
330d
Days
Class 2
Risk

About This 510(k) Submission

K123977 is an FDA 510(k) clearance for the RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on November 21, 2013, 330 days after receiving the submission on December 26, 2012. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K123977 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 2012
Decision Date November 21, 2013
Days to Decision 330 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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