510(k) K080916
- Device
- CAPILLARYS URINE
- Applicant
- SEBIA
- 510(k) number
- K080916
- Product code
- JKM
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-07-01
- Date received
- 2008-04-02
- Regulation
- 866.5150
- Classification name
- Immunochemical, Bence-jones Protein
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- KAREN ANDERSON
- Address
- 400-1705 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 |
|---|---|---|---|
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | 2007-12-21 |
| 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 |
Legacy Summary#
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FDA Review#
Decision Summary