FDA 510(k) Application Details - K962819

Device Classification Name	Enzyme Immunoassay, Gentamicin   More FDA Info for this Device
510(K) Number	K962819
Device Name	Enzyme Immunoassay, Gentamicin
Applicant	DADE INTL., INC. BUILDING 500, MAILBOX 514 P.O. BOX 6101 NEWARK, DE 19714-6101 US Other 510(k) Applications for this Company
Contact	CAROLYN K GEORGE 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	07/19/1996
Decision Date	09/13/1996
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