FDA 510(k) Application Details - K062966

Device Classification Name	Lamotrigine Assay   More FDA Info for this Device
510(K) Number	K062966
Device Name	Lamotrigine Assay
Applicant	SERADYN INC. 7998 GEORGETOWN RD. SUITE 1000 INDIANAPOLIS, IN 46268-5260 US Other 510(k) Applications for this Company
Contact	JACK ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3350   More FDA Info for this Regulation Number
Classification Product Code	ORH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2006
Decision Date	01/12/2007
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