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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
510(k) Number K201049
Device Name FINDER G6PD
Applicant
Baebies, Inc.
615 Davis Dr., Suite 800
Morrisville,  NC  27560
Applicant Contact Ailen Gillette
Correspondent
Baebies, Inc.
25 Alexandria Way,
Durham,  NC  27703
Correspondent Contact Candice Prowse
Regulation Number864.7360
Classification Product Code
JBF  
Date Received04/21/2020
Decision Date 09/14/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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