JKM — Immunochemical, Bence-Jones Protein Class II
FDA Device Classification
Classification Details
- Product Code
- JKM
- Device Class
- Class II
- Regulation Number
- 866.5150
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K080916 | sebia | CAPILLARYS URINE | July 1, 2008 |
| K070486 | sebia | CAPILLARYS URINE (PN 2012) | December 21, 2007 |
| K050119 | beckman coulter | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY S | May 6, 2005 |
| K972591 | morax | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES | March 4, 1998 |