FDA 510(k) Application Details - K060998

Device Classification Name	Fluorescent Immunoassay, Tobramycin   More FDA Info for this Device
510(K) Number	K060998
Device Name	Fluorescent Immunoassay, Tobramycin
Applicant	SERADYN, INC. 7998 GEORGETOWN RD., STE. 1000 INDIANAPOLIS, IN 46268-5260 US Other 510(k) Applications for this Company
Contact	EARL E KNIGHT III Other 510(k) Applications for this Contact
Regulation Number	862.3900   More FDA Info for this Regulation Number
Classification Product Code	LCR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/11/2006
Decision Date	07/21/2006
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