JKM · Class II · 21 CFR 866.5150

FDA Product Code JKM: Immunochemical, Bence-jones Protein

Leading manufacturers include Beckman Coulter, Inc., Sebia and Morax.

4
Total
4
Cleared
185d
Avg days
1998
Since

FDA 510(k) Cleared Immunochemical, Bence-jones Protein Devices (Product Code JKM)

4 devices
1–4 of 4
Cleared Jul 01, 2008
CAPILLARYS URINE
K080916
Sebia
Immunology · 90d
Cleared May 06, 2005
PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT
K050119
Beckman Coulter, Inc.
Immunology · 108d
Cleared Mar 04, 1998
HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
K972591
Morax
Immunology · 236d

About Product Code JKM - Regulatory Context