FDA 510(k) Application Details - K960493

Device Classification Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum   More FDA Info for this Device
510(K) Number	K960493
Device Name	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Applicant	PYRAMID BIOLOGICAL CORP. 6454 VAN NUYS BLVD., SUITE 111 VAN NUYS, CA 91401 US Other 510(k) Applications for this Company
Contact	JEANETTE R PORRETTA Other 510(k) Applications for this Contact
Regulation Number	866.3830   More FDA Info for this Regulation Number
Classification Product Code	LIP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/01/1996
Decision Date	06/17/1996
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