FDA 510(k) Application Details - K993107

Device Classification Name	Urinary Homocystine (Nonquantitative) Test System   More FDA Info for this Device
510(K) Number	K993107
Device Name	Urinary Homocystine (Nonquantitative) Test System
Applicant	BIO-RAD 4000 ALFRED NOBEL DR. HERCULES, CA 94547-1803 US Other 510(k) Applications for this Company
Contact	Patricia M Klimley Other 510(k) Applications for this Contact
Regulation Number	862.1377   More FDA Info for this Regulation Number
Classification Product Code	LPS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/1999
Decision Date	12/21/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review