CKMB UDR ASSAY— 510(k) K102706

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K102706 for CKMB UDR ASSAY, Substantially Equivalent on 2011-08-19. Applicant: SENTINEL CH. SpA. Device class: 2.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code JHS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2010-09-20
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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