CAPI 3 HEMOGLOBIN(E)
FDA 510(k) clearance K180762 · decided 2018-12-14
Clearance details
- K-number
- K180762
- Device name
- CAPI 3 HEMOGLOBIN(E)
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2018-03-23
- Decision date
- 2018-12-14
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- GKA
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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.