FDA 510(k) Applications for Medical Device Product Code "DON"
(Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Solid Phase Sep.)

FDA 510(k) Number Applicant Device Name Decision Date
K803075 ABBOTT LABORATORIES DIGOXIN RIABEAD DIAGNOSTIC KIT 12/22/1980
K772098 BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC DIGOXIN REAG. KIT FOR USE W/ARIA-II SYS 12/20/1977
K772422 BIO-RAD QUANTIMUNE DIGOXIN RIA/DIGOXIN RIA 02/13/1978
K822053 BIOLOGICAL & DIAGNOSTIC PRODUCTS ZETAPHASE-DIG 07/27/1982
K770269 BURROUGHS WELLCOME CO. CAMMADISK DIGOXIN 03/16/1977
K780475 BURROUGHS WELLCOME CO. DAC-CEL DIGOXIN RADIOIMMUNOASSAY KIT 04/24/1978
K902861 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING ACS DIGOXIN IMMUNOASSAY 09/10/1990
K881679 CIBA CORNING DIAGNOSTICS CORP. CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY 07/08/1988
K840461 CORNING MEDICAL & SCIENTIFIC MAGIC 125I DIGOXIN RADIOIMMUNOASSAY 03/23/1984
K780207 DAMON CORP. LIQUISOL DIGOXIN RIA TEST KIT 02/23/1978
K781660 E. R. SQUIBB & SONS, INC. RIA, DIGOXIN 10/24/1978
K821000 ICL SCIENTIFIC ENZYMUNE-TEST DIGOXIN 04/26/1982
K760800 MALLINCKRODT CRITICAL CARE SPAC DIGOXIN KIT 11/01/1976
K830533 MEDICAL & SCIENTIFIC DESIGNS, INC. PHASE II DIGOXIN RADIOIMMUNOASSAY KIT 04/05/1983
K810296 RIA DIAGNOSTICS DIGOXIN RIA ASSAY 02/19/1981
K791549 TECHNICON INSTRUMENTS CORP. TECHNICON STAR SYSTEM 09/27/1979
K771255 UNION CARBIDE CORP. CEBTRIA DIGOXIN RIA 08/25/1977


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