FDA 510(k) Application Details - K051211

Device Classification Name	Immunoassay, Anti-Seizure Drug   More FDA Info for this Device
510(K) Number	K051211
Device Name	Immunoassay, Anti-Seizure Drug
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	NWM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/2005
Decision Date	11/18/2005
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