510(k) K964635

NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT by Nichols Institute Diagnostics — Product Code JKR

K964635 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT". The FDA issued a decision of Substantially Equivalent on May 21, 1997. The device falls under product code JKR (Radioimmunoassay, Calcitonin), a Class II device regulated under 21 CFR 862.1140. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.