CAPI 3 HEMOGLOBIN(E)

Abnormal Hemoglobin Quantitation

SEBIA

The following data is part of a premarket notification filed by Sebia with the FDA for Capi 3 Hemoglobin(e).

Pre-market Notification Details

Device IDK180762
510k NumberK180762
Device Name:CAPI 3 HEMOGLOBIN(E)
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 Received2018-03-23
Decision Date2018-12-14
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.