Cleared Special

MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB

K022654 · Roche Diagnostics Corp. · Chemistry
Aug 2002
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K022654 is an FDA 510(k) clearance for the MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Roche Diagnostics Corp. (Indianapolis, US). The FDA issued a Cleared decision on August 29, 2002, 20 days after receiving the submission on August 9, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K022654 FDA.gov
FDA Decision Cleared SESE
Date Received August 09, 2002
Decision Date August 29, 2002
Days to Decision 20 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHY — Colorimetric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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