Cleared Traditional

CK QVET

K950177 · Prisma Systems · Chemistry
Mar 1995
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K950177 is an FDA 510(k) clearance for the CK QVET, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Prisma Systems (Rome, US). The FDA issued a Cleared decision on March 3, 1995, 45 days after receiving the submission on January 17, 1995. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K950177 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1995
Decision Date March 03, 1995
Days to Decision 45 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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