FDA 510(k) Application Details - K993633

Device Classification Name	Antigens, Nontreponemal, All   More FDA Info for this Device
510(K) Number	K993633
Device Name	Antigens, Nontreponemal, All
Applicant	CENTERS FOR DISEASE CONTROL AND PREVENTION 1600 CLIFTON RD., N.E. ATLANTA, GA 30333 US Other 510(k) Applications for this Company
Contact	VICTORIA POPE Other 510(k) Applications for this Contact
Regulation Number	866.3820   More FDA Info for this Regulation Number
Classification Product Code	GMQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/27/1999
Decision Date	02/23/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review