510(k) K052645

VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; by Ortho-Clinical Diagnostics — Product Code GTQ

K052645 is an FDA 510(k) premarket notification submitted by Ortho-Clinical Diagnostics for the device "VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873;". The FDA issued a decision of Substantially Equivalent on December 14, 2005. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Ortho-Clinical Diagnostics has at least 10 other 510(k) clearances on record.