Cleared Traditional

SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS

K051648 · Arkray, Inc. · Chemistry
Jan 2006
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K051648 is an FDA 510(k) clearance for the SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Arkray, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on January 31, 2006, 224 days after receiving the submission on June 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K051648 FDA.gov
FDA Decision Cleared SESE
Date Received June 21, 2005
Decision Date January 31, 2006
Days to Decision 224 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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