FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVADER MTHFR 1298
K Number: K100496
·
Decision Apr 25, 2011
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
1
Applicant Total
116
Review Days
427
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Basic Information
- Device Name
- INVADER MTHFR 1298
- K Number
- K100496
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7280
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hologic, Inc.
- Date Received
- February 22, 2010
- Decision Date
- April 25, 2011
- Product Code
- OMM
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OMM | Test 5, 10-Methylenetetrahydrofolate Reductase Mutations, Genomic Dna Pcr | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OMM), ordered by most recent decision date.
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