FDA 510(k) Application Details - K984268

Device Classification Name	Assay, Glycosylated Hemoglobin   More FDA Info for this Device
510(K) Number	K984268
Device Name	Assay, Glycosylated Hemoglobin
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	864.7470   More FDA Info for this Regulation Number
Classification Product Code	LCP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/30/1998
Decision Date	12/17/1998
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