FDA 510(k) Applications for Medical Device Product Code "OMM"
(Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr)

FDA 510(k) Number Applicant Device Name Decision Date
K100496 HOLOGIC, INC. INVADER MTHFR 1298 04/25/2011
K100987 HOLOGIC, INC. INVADER MTHFR 677 05/13/2011


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