FDA 510(k) Application Details - K093974

Device Classification Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K093974
Device Name	Test, Factor V Leiden Mutations, Genomic Dna Pcr
Applicant	OSMETECH MOLECULAR DIAGNOSTICS 757 SOUTH RAYMOND AVE. PASADENA, CA 91105 US Other 510(k) Applications for this Company
Contact	ROBERT S DICHECK Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	NPQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2009
Decision Date	04/22/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review