FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INVADER FACTOR II
K Number: K100943
·
Decision Jun 2, 2011
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
116
Review Days
422
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Basic Information
- Device Name
- INVADER FACTOR II
- K Number
- K100943
- 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
- April 6, 2010
- Decision Date
- June 2, 2011
- Product Code
- NPR
- 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 |
|---|---|---|---|
| NPR | Test, Factor Ii G20210a Mutations, Genomic Dna Pcr | FDA class 2 | Hematology |
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