OMM · Class II · 21 CFR 864.7280

FDA Product Code OMM: Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

In Vitro Diagnostic For The Detection And Genotyping Of A Single Point Mutation Of The Human 5, 10-methylenetetrahydrofolate Reductase Gene (mthfr) In Patients With Suspected Thrombophilia.

Leading manufacturers include Hologic, Inc..

2
Total
2
Cleared
413d
Avg days
2011
Since

FDA 510(k) Cleared Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr Devices (Product Code OMM)

2 devices
1–2 of 2
Cleared May 13, 2011
INVADER MTHFR 677
K100987
Hologic, Inc.
Pathology · 399d
Cleared Apr 25, 2011
INVADER MTHFR 1298
K100496
Hologic, Inc.
Pathology · 427d

About Product Code OMM - Regulatory Context