FDA 510(k) Application Details - K971502

Device Classification Name	Antigens, Ha, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K971502
Device Name	Antigens, Ha, Treponema Pallidum
Applicant	SCIMEDX TEKFILE SERVICES 400 FORD RD. DENVILL, NJ 07834 US Other 510(k) Applications for this Company
Contact	Gary Lehnus Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	GMT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/1997
Decision Date	11/13/1997
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