CAPI 3 HEMOGLOBIN(E)— 510(k) K180762
Substantially EquivalentSebia
FDA 510(k) clearance K180762 for CAPI 3 HEMOGLOBIN(E), Substantially Equivalent on 2018-12-14. Applicant: Sebia. Device class: 2.
Clearance details
- Applicant
- Sebia
- Product code
- Code GKA
- Device class
- Class 2
- Regulation
- 21 CFR 864.7415
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norcross, GA, US
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More clearances from Sebia
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