CAPILLARYS URINE

Immunochemical, Bence-jones Protein

SEBIA

The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Urine.

Pre-market Notification Details

Device IDK080916
510k NumberK080916
Device Name:CAPILLARYS URINE
ClassificationImmunochemical, Bence-jones Protein
Applicant SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
ContactKaren Anderson
CorrespondentKaren Anderson
SEBIA 400-1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
Product CodeJKM  
CFR Regulation Number866.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-04-02
Decision Date2008-07-01

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