FDA 510(k) Application Details - K052826

Device Classification Name	Enzyme Immunoassay, Quinidine   More FDA Info for this Device
510(K) Number	K052826
Device Name	Enzyme Immunoassay, Quinidine
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	862.3320   More FDA Info for this Regulation Number
Classification Product Code	LBZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/05/2005
Decision Date	12/23/2005
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