FDA 510(k) Application Details - K020595

Device Classification Name	Kit, Screening, Trichomonas   More FDA Info for this Device
510(K) Number	K020595
Device Name	Kit, Screening, Trichomonas
Applicant	XENOTOPE DIAGNOSTICS, INC. 9418 LASAINE AVE. NORTHRIDGE, CA 91325 US Other 510(k) Applications for this Company
Contact	ROBIN J HELLEN Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	JWZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/22/2002
Decision Date	02/20/2003
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