Cleared Traditional

CPK REAGENT

K112416 · Vital Diagnostics (Manufacturing) Ptyltd · Chemistry
Nov 2011
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K112416 is an FDA 510(k) clearance for the CPK REAGENT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Vital Diagnostics (Manufacturing) Ptyltd (Noble Park, AU). The FDA issued a Cleared decision on November 9, 2011, 79 days after receiving the submission on August 22, 2011. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K112416 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 2011
Decision Date November 09, 2011
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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