510(k) K100496
- Device
- INVADER MTHFR 1298
- Applicant
- HOLOGIC, INC.
- 510(k) number
- K100496
- Product code
- OMM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2011-04-25
- Date received
- 2010-02-22
- Regulation
- 864.7280
- Classification name
- Test 5, 10-methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr
- Medical specialty
- Hematology
- Review panel
- Pathology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- RANDALL J COVILL
- Address
- 250 Campus Dr. Malborough MA US 01752 01752
FDA Registration Numbers#
- 3005406097
Source Documents#
Other 510(k) Records For Product Code OMM #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K100987 | INVADER MTHFR 677 | Hologic, Inc. | 2011-05-13 |
Legacy Summary#
summary
FDA Review#
Decision Summary