FDA 510(k) Application Details - K990827

Device Classification Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase   More FDA Info for this Device
510(K) Number	K990827
Device Name	Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
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	862.1315   More FDA Info for this Regulation Number
Classification Product Code	KQP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/1999
Decision Date	04/09/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review