Invader Mthfr 1298
FDA 510(k) K100496 · Hologic, Inc.
510(k) numberK100496
Submission
- Device name
- Invader Mthfr 1298
- Applicant
- Hologic, Inc.
Malborough, MA, US - Received
- February 22, 2010
- Decision date
- April 25, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OMM – Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7280
- Specialty
- Hematology
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.
Other 510(k)s with product code OMM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K100987 | Invader Mthfr 677OMM · Traditional | Hologic, Inc. | 05/13/2011SE |
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Questions and answers
When was Invader Mthfr 1298 cleared by the FDA?
Invader Mthfr 1298 (K100496) received a 510(k) decision of Substantially Equivalent on April 25, 2011, 427 days after the submission was received.
What is the product code of K100496?
The FDA product code is OMM – Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr, a Class II (moderate risk) device regulated under 21 CFR 864.7280.