Cleared Special

ELECSYS CK-MB STAT IMMUNOASSAY

K140404 · Roche Diagnostics · Chemistry
May 2014
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K140404 is an FDA 510(k) clearance for the ELECSYS CK-MB STAT IMMUNOASSAY, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Roche Diagnostics (Indianapolos, US). The FDA issued a Cleared decision on May 8, 2014, 79 days after receiving the submission on February 18, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K140404 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2014
Decision Date May 08, 2014
Days to Decision 79 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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