FDA 510(k) Application Details - K033864

Device Classification Name	Kit, Screening, Trichomonas   More FDA Info for this Device
510(K) Number	K033864
Device Name	Kit, Screening, Trichomonas
Applicant	GENZYME CORP. ONE KENDALL SQUARE CAMBRIDGE, MA 02139 US Other 510(k) Applications for this Company
Contact	E.V. GOORCHENKO 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	12/12/2003
Decision Date	04/02/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review