510(k) K912536

CALCITONIN KIT MITSUBISHI YUKA by Mitsubishi Yuka America, Inc. — Product Code JKR

K912536 is an FDA 510(k) premarket notification submitted by Mitsubishi Yuka America, Inc. for the device "CALCITONIN KIT MITSUBISHI YUKA". The FDA issued a decision of Substantially Equivalent on July 18, 1991. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Mitsubishi Yuka America, Inc. has at least 1 other 510(k) clearance on record.