CAPILLARYS IMMUNOTYPING, MODEL 2100
FDA 510(k) clearance K082085 · decided 2009-04-17
Clearance details
- K-number
- K082085
- Device name
- CAPILLARYS IMMUNOTYPING, MODEL 2100
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2008-07-23
- Decision date
- 2009-04-17
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- CFF
- Device class
- 2
- Regulation number
- 866.5510
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.