510(k) K841056

HDL PRECIPITANT REAGENT SET by Medical Specialties, Inc. — Product Code JHM

K841056 is an FDA 510(k) premarket notification submitted by Medical Specialties, Inc. for the device "HDL PRECIPITANT REAGENT SET". The FDA issued a decision of Substantially Equivalent on May 1, 1984. The device falls under product code JHM (Colorimetric Method, Lipoproteins), a Class I device regulated under 21 CFR 862.1475. Medical Specialties, Inc. has at least 10 other 510(k) clearances on record.