510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OMMClass II

Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr

21 CFR 864.7280 / Hematology
FDA source (opens on fda.gov)

OMM is the FDA product code for Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr, a class II device type, regulated under 21 CFR 864.7280. FDA's definition for this code reads: "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". As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
OMM
Device name
Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
FDA definition
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.
Regulation
21 CFR 864.7280
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code OMM

By decision year
2 clearances under product code OMM with a decision year between 2011 and 2011, 2011 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code OMM by decision year
YearClearances
20112

Applicants with the most clearances

Product code OMM
Applicants holding the most 510(k) clearances under product code OMM
ApplicantClearances
Hologic, Inc.2

Companies listing this code with FDA

Companies whose registered establishments list this code