Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening

Baebies, Inc.

The following data is part of a premarket notification filed by Baebies, Inc. with the FDA for Finder G6pd.

Pre-market Notification Details

Device IDK201049
510k NumberK201049
Device Name:FINDER G6PD
ClassificationGlucose-6-phosphate Dehydrogenase (erythrocytic), Screening
Applicant Baebies, Inc. 615 Davis Drive Suite 800 Morrisville,  NC  27560
ContactAilen Gillette
CorrespondentCandice Prowse
Baebies, Inc. 25 Alexandria Way Durham,  NC  27703
Product CodeJBF  
CFR Regulation Number864.7360 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-21
Decision Date2022-09-14

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