FDA 510(k) Application Details - K963733

Device Classification Name	Test System, Nicotine, Cotinine, Metabolites   More FDA Info for this Device
510(K) Number	K963733
Device Name	Test System, Nicotine, Cotinine, Metabolites
Applicant	DYNAGEN, INC. 99 ERIE ST. CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	PETER J MIONE Other 510(k) Applications for this Contact
Regulation Number	862.3220   More FDA Info for this Regulation Number
Classification Product Code	MRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/16/1996
Decision Date	12/13/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review