FDA 510(k) Application Details - K991127

Device Classification Name	Hemoglobin A2 Quantitation   More FDA Info for this Device
510(K) Number	K991127
Device Name	Hemoglobin A2 Quantitation
Applicant	BIO-RAD 4000 ALFRED NOBEL DR. HERCULES, CA 94547-1803 US Other 510(k) Applications for this Company
Contact	JULIET CARRARA 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	04/02/1999
Decision Date	06/10/1999
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