Cleared Traditional

ROCHE DIAGNOSTICS CK-MB

K003158 · Roche Diagnostics Corp. · Chemistry
Dec 2000
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K003158 is an FDA 510(k) clearance for the ROCHE DIAGNOSTICS CK-MB, a U.v. Method, Cpk Isoenzymes (Class II — Special Controls, product code JHW), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on December 18, 2000, 69 days after receiving the submission on October 10, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K003158 FDA.gov
FDA Decision Cleared SESE
Date Received October 10, 2000
Decision Date December 18, 2000
Days to Decision 69 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHW — U.v. Method, Cpk Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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