CAPI 3 Hb A1c

Hemoglobin A1c Test System

Sebia

The following data is part of a premarket notification filed by Sebia with the FDA for Capi 3 Hb A1c.

Pre-market Notification Details

Device IDK171537
510k NumberK171537
Device Name:CAPI 3 Hb A1c
ClassificationHemoglobin A1c Test System
Applicant Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30093
ContactKaren Aderson
CorrespondentKaren Aderson
Sebia 1705 Corporate Drive Suite 400 Norcross,  GA  30093
Product CodePDJ  
CFR Regulation Number862.1373 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-05-25
Decision Date2017-09-12
Summary:summary

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