CAPILLARYS URINE (PN 2012)— 510(k) K070486
Substantially EquivalentSebia, Inc.
FDA 510(k) clearance K070486 for CAPILLARYS URINE (PN 2012), Substantially Equivalent on 2007-12-21. Applicant: Sebia, Inc.. Device class: 2.
Clearance details
- Applicant
- Sebia, Inc.
- 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
- Traditional
- Location
- Norcross, GA, US
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