FDA 510(k) Application Details - K200904

Device Classification Name	More FDA Info for this Device
510(K) Number	K200904
Device Name	Tosoh Automated Glycohemoglobin Analyzer HLC-723G8
Applicant	Tosoh Bioscience, Inc. 6000 Shoreline Court, Suite 101 South San Francisco, CA 94080 US Other 510(k) Applications for this Company
Contact	Louise Musante Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PDJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2020
Decision Date	08/05/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review