CRP Vario

Cardiac 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 IDK173833
510k NumberK173833
Device Name:CRP Vario
ClassificationCardiac C-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 CodeNQD  
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-18
Decision Date2018-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740158507 K173833 000
00380740158491 K173833 000

Trademark Results [CRP Vario]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CRP VARIO
CRP VARIO
78605705 3156677 Live/Registered
De Luca, Ugo
2005-04-11
CRP VARIO
CRP VARIO
78605705 3156677 Live/Registered
Roveda, Luigi
2005-04-11

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