CAPILLARYS NEONAT HB (PN 2006)

Abnormal Hemoglobin Quantitation

SEBIA

The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Neonat Hb (pn 2006).

Pre-market Notification Details

Device IDK091283
510k NumberK091283
Device Name:CAPILLARYS NEONAT HB (PN 2006)
ClassificationAbnormal Hemoglobin Quantitation
Applicant SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
ContactKaren Anderson
CorrespondentKaren Anderson
SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross,  GA  30093
Product CodeGKA  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-05-01
Decision Date2010-02-22

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