Cleared Traditional

Dimension Vista MMB Assay

K143720 · Siemens Healthcare Diagnostics · Chemistry
Sep 2015
Decision
263d
Days
Class 2
Risk

About This 510(k) Submission

K143720 is an FDA 510(k) clearance for the Dimension Vista MMB Assay, a Colorimetric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHY), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on September 18, 2015, 263 days after receiving the submission on December 29, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K143720 FDA.gov
FDA Decision Cleared SESE
Date Received December 29, 2014
Decision Date September 18, 2015
Days to Decision 263 days
Submission Type Traditional
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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