CAPILLARYS URINE
FDA 510(k) clearance K080916 · decided 2008-07-01
Clearance details
- K-number
- K080916
- Device name
- CAPILLARYS URINE
- Applicant
- Sebia
- Decision
- Substantially Equivalent
- Date received
- 2008-04-02
- Decision date
- 2008-07-01
- Days to decision
- 90 days
- Clearance type
- Special
- Product code
- JKM
- Device class
- 2
- Regulation number
- 866.5150
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Norcross, GA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119) | Beckman Coulter, Inc. | 2005-05-06 |
| HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT (K972591) | Morax | 1998-03-04 |
Recalls involving this device
No recalls on record reference this clearance.