INVADER FACTOR II
FDA 510(k) clearance K100943 · decided 2011-06-02
Clearance details
- K-number
- K100943
- Device name
- INVADER FACTOR II
- Applicant
- Hologic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2010-04-06
- Decision date
- 2011-06-02
- Days to decision
- 422 days
- Clearance type
- Traditional
- Product code
- NPR
- 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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No recalls on record reference this clearance.
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