FDA 510(k) Application Details - K012311

Device Classification Name	Enzyme Immunoassay, Gentamicin   More FDA Info for this Device
510(K) Number	K012311
Device Name	Enzyme Immunoassay, Gentamicin
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	LCD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/23/2001
Decision Date	08/20/2001
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