SENTINEL CLIN CHEM CAL

Calibrator, Multi-analyte Mixture

SENTINEL CH. SRL

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

Pre-market Notification Details

Device IDK051452
510k NumberK051452
Device Name:SENTINEL CLIN CHEM CAL
ClassificationCalibrator, Multi-analyte Mixture
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 CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-02
Decision Date2005-10-25
Summary:summary

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