FDA 510(k) Applications for Medical Device Product Code "DPO"
(Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Coated Tube Sep.)

FDA 510(k) Number Applicant Device Name Decision Date
K771638 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC IGOXIN SOLID PHASE RIA 10/07/1977
K905719 BIOTOPE, INC. ECLIPSE ICA DIGOXIN 01/17/1991
K800205 BOEHRINGER MANNHEIM CORP. RIA PHASE DIGOXIN 03/19/1980
K864449 CANADIAN BIOCLINICAL, LTD. DIGOXIN/RIA KIT COATED TUBE RADIOIMMUNOASSAY KIT 02/02/1987
K914833 CIRRUS DIAGNOSTICS, INC. IMMULITE DIGOXIN 11/22/1991
K811932 DIAGNOSTIC PRODUCTS CORP. COAT-A-COUNT DIGOXIN RIA 07/23/1981
K832163 DIAGNOSTIC PRODUCTS CORP. SOPHEIA DIGOXIN EIA KIT 08/12/1983
K770069 E. R. SQUIBB & SONS, INC. DIGOXIN CLASP TM RIA KIT 01/18/1977
K830962 IMMUCHEM CORP. IMMUCHEM COVALENT-COAT RIA KIT 05/04/1983
K833842 IMMUNO ASSAY CORP. RIA COAT DIGOXIN 01/17/1984
K811776 KALLESTAD LABORATORIES, INC. KALLESTAD QUANTICOAT 125 DIGOXIN 07/10/1981
K791325 MICROMEDIC SYSTEMS AUTOPAK 12 DIGOXIN TEST DELIVERY SYSTEM 08/16/1979
K770365 TRAVENOL LABORATORIES, S.A. RADIOIMMUNOASSAY DIGOXIN TEST, IN VITRO 02/24/1977
K791355 VENTREX LABORATORIES, INC. VENTRE/SEP DIGOXIN RADIOIMMUNOASSAY KIT 08/10/1979


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