Cleared Traditional

CK-NAC REAGENT

K974833 · Intersect Systems, Inc. · Chemistry
Feb 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K974833 is an FDA 510(k) clearance for the CK-NAC REAGENT, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Intersect Systems, Inc. (Longview, US). The FDA issued a Cleared decision on February 13, 1998, 51 days after receiving the submission on December 24, 1997. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K974833 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1997
Decision Date February 13, 1998
Days to Decision 51 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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