SENTINEL CERULOPLASMIN

Indirect Copper Assay, Ceruloplasmin

SENTINEL CH. SRL

The following data is part of a premarket notification filed by Sentinel Ch. Srl with the FDA for Sentinel Ceruloplasmin.

Pre-market Notification Details

Device IDK051456
510k NumberK051456
Device Name:SENTINEL CERULOPLASMIN
ClassificationIndirect Copper Assay, Ceruloplasmin
Applicant SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano,  IT 20155
ContactDavide Spada
CorrespondentDavide Spada
SENTINEL CH. SRL 5 VIA PRINCIPE EUGENIO Milano,  IT 20155
Product CodeJFR  
CFR Regulation Number866.5210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-02
Decision Date2005-10-21
Summary:summary

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