FDA 510(k) Application Details - K201049

Device Classification Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening   More FDA Info for this Device
510(K) Number	K201049
Device Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Applicant	Baebies, Inc. 615 Davis Drive Suite 800 Morrisville, NC 27560 US Other 510(k) Applications for this Company
Contact	Ailen Gillette Other 510(k) Applications for this Contact
Regulation Number	864.7360   More FDA Info for this Regulation Number
Classification Product Code	JBF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/21/2020
Decision Date	09/14/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review