CRP Vario

C-reactive Protein, Antigen, Antiserum, And Control

Sentinel CH, Spa

The following data is part of a premarket notification filed by Sentinel Ch, Spa with the FDA for Crp Vario.

Pre-market Notification Details

Device IDK192118
501k NumberK192118
Device Name:CRP Vario
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
Applicant Sentinel CH, Spa Via Robert Koch, 2 Milano,  IT 20152
ContactPatricia Dupe
CorrespondentPatricia Dupe
Sentinel CH, Spa Via Robert Koch, 2 Milano,  IT 20152
Product CodeDCK  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyImmunology
501k Review PanelImmunology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-08-06
Decision Date2019-11-08

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