FDA 510(k) Application Details - K020489

Device Classification Name	Hemoglobin A2 Quantitation   More FDA Info for this Device
510(K) Number	K020489
Device Name	Hemoglobin A2 Quantitation
Applicant	TOSOH MEDICS, INC. 347 OYSTER POINT BLVD., SUITE 201 SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	LOIS NAKAYAMA Other 510(k) Applications for this Contact
Regulation Number	864.7400   More FDA Info for this Regulation Number
Classification Product Code	JPD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2002
Decision Date	05/14/2002
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