FDA 510(k) Applications for Medical Device Product Code "CFT"
(Radioimmunoassay, Prolactin (Lactogen))

FDA 510(k) Number Applicant Device Name Decision Date
K964748 BOEHRINGER MANNHEIM CORP. ELECSYS PROLACTIN ASSAY 01/21/1997
K960561 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE PROLACTIN ELISA MODEL 10-4500 04/26/1996
K960060 DIAGNOSTIC SYSTEMS LABORATORIES, INC. DSL ACTIVE PROLACTIN IRMA 02/29/1996
K970281 JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. VITROS IMMUNODIAGNOSTIC PRODUCTS PROLACTIN REAGENT PACK/CALIBRATORS 02/25/1997
K971921 MONOBIND PROLACTIN (PRL) HORMONE MICROPLATE ELISA 06/24/1997
K970188 SEALITE SCIENCES, INC. SEALITE SCIENCES, INC. AQUALITE PROLACTIN 02/20/1997


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