Cleared Traditional

N-ASSAY CPK-L

K980900 · Crestat Diagnostics, Inc. · Chemistry
Mar 1998
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K980900 is an FDA 510(k) clearance for the N-ASSAY CPK-L, a Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes (Class II — Special Controls, product code CGS), submitted by Crestat Diagnostics, Inc. (Seattle, US). The FDA issued a Cleared decision on March 26, 1998, 16 days after receiving the submission on March 10, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K980900 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 1998
Decision Date March 26, 1998
Days to Decision 16 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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