FDA 510(k) Applications for Medical Device Product Code "JIW"
(Calibrator, Surrogate)

FDA 510(k) Number Applicant Device Name Decision Date
K970396 DADE CHEMISTRY SYSTEMS, INC. HUMAN CHORIONIC GONADOTROPIN CALIBRATOR 02/20/1997
K973055 WAKO CHEMICALS, USA, INC. WAKO CH50 LINEARITY SET 09/25/1997


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