FDA 510(k) Application Details - K993028

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K993028
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	SYVA CO. 3403 YERBA BUENA RD. SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	PAUL L ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3645   More FDA Info for this Regulation Number
Classification Product Code	KLT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/09/1999
Decision Date	01/27/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review