FDA 510(k) Application Details - K161364

Device Classification Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening   More FDA Info for this Device
510(K) Number	K161364
Device Name	Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Applicant	ALERE SCARBOROUGH, INC. 10 SOUTHGATE ROAD Scarborough, ME 04074 US Other 510(k) Applications for this Company
Contact	Angela Drysdale 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	05/17/2016
Decision Date	06/17/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review