510(k) K972591

HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT by Morax — Product Code JKM

K972591 is an FDA 510(k) premarket notification submitted by Morax for the device "HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT". The FDA issued a decision of Substantially Equivalent on March 4, 1998. The device falls under product code JKM (Immunochemical, Bence-Jones Protein), a Class II device regulated under 21 CFR 866.5150. Morax has at least 10 other 510(k) clearances on record.