CRP Vario— 510(k) K192118

Substantially Equivalent

SENTINEL CH. SpA

FDA 510(k) clearance K192118 for CRP Vario, Substantially Equivalent on 2019-11-08. Applicant: SENTINEL CH. SpA. Device class: 2.

Clearance details

Applicant: SENTINEL CH. SpA
Product code: Code DCK
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2019-08-06
Decision date: 2019-11-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Milan, IT

Download summary PDF View on FDA.gov ↗

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