FDA 510(k) Application Details - K100987

Device Classification Name	Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr   More FDA Info for this Device
510(K) Number	K100987
Device Name	Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
Applicant	HOLOGIC, INC. 250 CAMPUS DRIVE MARLBOROUGH, MA 01752 US Other 510(k) Applications for this Company
Contact	RANDALL COVILL Other 510(k) Applications for this Contact
Regulation Number	864.7280   More FDA Info for this Regulation Number
Classification Product Code	OMM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/09/2010
Decision Date	05/13/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	PA - Pathology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review