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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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