FDA 510(k) Application Details - K063398

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K063398
Device Name	Drug Mixture Control Materials
Applicant	BIONOSTICS, INC. 7 JACKSON RD. DEVENS, MA 01434 US Other 510(k) Applications for this Company
Contact	RANDY BYRD Other 510(k) Applications for this Contact
Regulation Number	862.3280   More FDA Info for this Regulation Number
Classification Product Code	DIF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/09/2006
Decision Date	12/05/2006
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