510(k) K171168

VITROS Immunodiagnostic Products Insulin Calibrators by Ortho Clinical Diagnostics — Product Code JIT

K171168 is an FDA 510(k) premarket notification submitted by Ortho Clinical Diagnostics for the device "VITROS Immunodiagnostic Products Insulin Calibrators". The FDA issued a decision of Substantially Equivalent on May 16, 2017. The device falls under product code JIT (Calibrator, Secondary), a Class II device regulated under 21 CFR 862.1150. Ortho Clinical Diagnostics has at least 10 other 510(k) clearances on record.