FDA 510(k) Application Details - K111363

Device Classification Name	Enzyme Immunoassay, Propoxyphene   More FDA Info for this Device
510(K) Number	K111363
Device Name	Enzyme Immunoassay, Propoxyphene
Applicant	MEDICA CORP. 5 OAK PARK DRIVE BEDFORD, MA 01730 US Other 510(k) Applications for this Company
Contact	Photios Makris Other 510(k) Applications for this Contact
Regulation Number	862.3700   More FDA Info for this Regulation Number
Classification Product Code	JXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/16/2011
Decision Date	12/06/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review