FDA Product Code
FDA Product Code JKM — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5150
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K080916 | CAPILLARYS URINE | Sebia | 2008-07-01 | Special | PDF ↗ |
| K070486 | CAPILLARYS URINE (PN 2012) | Sebia, Inc. | 2007-12-21 | Traditional | PDF ↗ |
| K050119 | PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT | Beckman Coulter, Inc. | 2005-05-06 | Traditional | PDF ↗ |
| K972591 | HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT | Morax | 1998-03-04 | Traditional | PDF ↗ |
Product code JKM · Class II · Immunology. Data: openFDA.