CAPILLARYS URINE— 510(k) K080916
Substantially EquivalentSebia
FDA 510(k) clearance K080916 for CAPILLARYS URINE, Substantially Equivalent on 2008-07-01. Applicant: Sebia. Device class: 2.
Clearance details
- Applicant
- Sebia
- Product code
- Code JKM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5150
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norcross, GA, US
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