FDA 510(k) Application Details - K973535

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K973535
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	SCHIAPPARELLI BIOSYSTEMS, INC. 368 PASSAIC AVE. FAIRFIELD, NJ 07004 US Other 510(k) Applications for this Company
Contact	STEVEN DALESSIO 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	09/18/1997
Decision Date	10/20/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review