FDA 510(k) Application Details - K092048

Device Classification Name	Enzyme Immunoassay, Methadone   More FDA Info for this Device
510(K) Number	K092048
Device Name	Enzyme Immunoassay, Methadone
Applicant	BIOSITE INCORPORATED 9975 SUMMERS RIDGE RD SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	Lisa Chicorka Other 510(k) Applications for this Contact
Regulation Number	862.3620   More FDA Info for this Regulation Number
Classification Product Code	DJR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2009
Decision Date	04/19/2010
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