FDA 510(k) Application Details - K063131

Device Classification Name	Enzyme Immunoassay, Carbamazepine   More FDA Info for this Device
510(K) Number	K063131
Device Name	Enzyme Immunoassay, Carbamazepine
Applicant	THERMO ELECTRON OY RATASTIE 2 PO BOX 100 VANTAA FIN-01621 FI Other 510(k) Applications for this Company
Contact	PAIVI SORMUNEN 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	10/13/2006
Decision Date	10/05/2007
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