FDA 510(k) Application Details - K964765

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K964765
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	CHIRON DIAGNOSTICS CORP. 63 NORTH ST. MEDFIELD, MA 02052 US Other 510(k) Applications for this Company
Contact	William J Pignato 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	11/27/1996
Decision Date	02/14/1997
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