FDA 510(k) Application Details - K050037

Device Classification Name	Drug Mixture Control Materials   More FDA Info for this Device
510(K) Number	K050037
Device Name	Drug Mixture Control Materials
Applicant	BIOSITE INCORPORATED 11030 ROSELLE ST. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	JEFFREY R DAHLEN 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	01/07/2005
Decision Date	03/22/2005
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