Product code JKM— Immunology

FDA has cleared 4 devices under product code JKM between 1998 and 2008, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20081 clearance
• 20071 clearance
• 20051 clearance
• 19981 clearance

• Sebia, Inc.1 clearance
• Sebia1 clearance
• Morax1 clearance
• Beckman Coulter, Inc.1 clearance

• K080916 — CAPILLARYS URINESebia·2008-07-01
• K070486 — CAPILLARYS URINE (PN 2012)Sebia, Inc.·2007-12-21
• K050119 — PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KITBeckman Coulter, Inc.·2005-05-06
• K972591 — HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KITMorax·1998-03-04