FDA 510(k) Application Details - K040352

Device Classification Name	Multi-Analyte Controls, All Kinds (Assayed)   More FDA Info for this Device
510(K) Number	K040352
Device Name	Multi-Analyte Controls, All Kinds (Assayed)
Applicant	BIORESOURCE TECHNOLOGY, INC. 1531 N.W. 65TH AVE. FORT LAUDERDALE, FL 33313-4542 US Other 510(k) Applications for this Company
Contact	ALAN POSNER Other 510(k) Applications for this Contact
Regulation Number	862.1660   More FDA Info for this Regulation Number
Classification Product Code	JJY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/12/2004
Decision Date	04/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review