FACTOR VIII ANTIBODY SCREEN
FDA 510(k) clearance K082205 · decided 2008-11-20
Clearance details
- K-number
- K082205
- Device name
- FACTOR VIII ANTIBODY SCREEN
- Applicant
- Genetic Testing Institute
- Decision
- Substantially Equivalent
- Date received
- 2008-08-05
- Decision date
- 2008-11-20
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- GGP
- Device class
- 2
- Regulation number
- 864.7290
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.