FDA 510(k) Applications for Medical Device Product Code "GTQ"
(Antistreptolysin - Titer/Streptolysin O Reagent)

FDA 510(k) Number Applicant Device Name Decision Date
K052645 ORTHO-CLINICAL DIAGNOSTICS VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PRODUCTS FS CALIBRATOR 1, REF 6801873; 12/14/2005


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact