FDA 510(k) Application Details - K011528

Device Classification Name	Enzyme Immunoassay, Phenobarbital   More FDA Info for this Device
510(K) Number	K011528
Device Name	Enzyme Immunoassay, Phenobarbital
Applicant	SYVA CO. 3403 YERBA BUENA RD. SAN JOSE, CA 95135-1500 US Other 510(k) Applications for this Company
Contact	SUSAN COLLINS Other 510(k) Applications for this Contact
Regulation Number	862.3660   More FDA Info for this Regulation Number
Classification Product Code	DLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2001
Decision Date	06/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review