INVADER MTHFR 1298
FDA 510(k) clearance K100496 · decided 2011-04-25
Clearance details
- K-number
- K100496
- Device name
- INVADER MTHFR 1298
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-02-22
- Decision date
- 2011-04-25
- Days to decision
- 427 days
- Clearance type
- Traditional
- Product code
- OMM
- Device class
- 2
- Regulation number
- 864.7280
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Malborough, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| INVADER MTHFR 677 (K100987) | Hologic, Inc. | 2011-05-13 |
Recalls involving this device
No recalls on record reference this clearance.
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