FDA 510(k) Applications for Medical Device Product Code "DOG"
(Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Polyethylene Glycol)

FDA 510(k) Number Applicant Device Name Decision Date
K803045 AMERICAN DADE IMMU-TRACE DIGOXIN (125I) RADIOIMMUN. 12/22/1980
K760416 DADE, BAXTER TRAVENOL DIAGNOSTICS, INC. DATA-TOPE SYSTEM DIGOXIN RIA 08/23/1976
K810477 DIAGNOSTIC CORP. OF AMERICA DCA DIGOX-SYN RIA TEST 03/11/1981
K781335 ORTHO DIAGNOSTICS, INC. DIGOXIN RIA (PEG) KIT 08/31/1978
K760709 SYVA CO. EMIT DIGOKIN ASSAY 10/21/1976


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