Immunochemical, Bence-Jones Protein
FDA product code JKM · Class II (moderate risk) · 21 CFR 866.5150 · Immunology
4510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080916 | Capillarys UrineJKM · Special | Sebia | 07/01/2008SE |
| K070486 | Capillarys Urine (PN 2012)JKM · Traditional | Sebia, Inc. | 12/21/2007SE |
| K050119 | Paragon Cze 2000 Urine Protein Electrophoresis Kit and Urine Immunofixation by…JKM · Traditional | Beckman Coulter, Inc. | 05/06/2005SE |
| K972591 | Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitJKM · Traditional | Morax | 03/04/1998SE |