510(k) K070486
- Device
- CAPILLARYS URINE (PN 2012)
- Applicant
- Sebia, Inc.
- 510(k) number
- K070486
- Product code
- JKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-12-21
- Date received
- 2007-02-20
- Regulation
- 866.5150
- Classification name
- Immunochemical, Bence-Jones Protein
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- KAREN ANDERSON
- Address
- 1705 Corporate Dr., Suite 400 Norcross GA US 30093 30093
FDA Registration Numbers#
- 8023024
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JKM#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080916 | CAPILLARYS URINE | Sebia | 2008-07-01 |
| K050119 | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT | Beckman Coulter, Inc. | 2005-05-06 |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | Morax | 1998-03-04 |