Cleared Traditional

CKMB UDR ASSAY

K102706 · SENTINEL CH. SpA · Chemistry
Aug 2011
Decision
333d
Days
Class 2
Risk

About This 510(k) Submission

K102706 is an FDA 510(k) clearance for the CKMB UDR ASSAY, a Differential Rate Kinetic Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHS), submitted by SENTINEL CH. SpA (Milano, IT). The FDA issued a Cleared decision on August 19, 2011, 333 days after receiving the submission on September 20, 2010. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K102706 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2010
Decision Date August 19, 2011
Days to Decision 333 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHS — Differential Rate Kinetic Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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