FDA 510(k) Application Details - K050419

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K050419
Device Name	Radioimmunoassay, Vancomycin
Applicant	SERADYN INC. 7998 GEORGETOWN RD. INDIANAPOLIS, IN 46268 US Other 510(k) Applications for this Company
Contact	JACK ROGERS Other 510(k) Applications for this Contact
Regulation Number	862.3950   More FDA Info for this Regulation Number
Classification Product Code	LEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2005
Decision Date	04/01/2005
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