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

FDA 510(k) Number Applicant Device Name Decision Date
K802841 AMERICAN DIAGNOSTIC CORP. DIGOXIN RADIOIMMUNOASSAY KIT 12/18/1980
K772110 CLINICAL ASSAYS, INC. IN VITRO DIGOXIN RIA TEST 11/22/1977
K810966 E. R. SQUIBB & SONS, INC. DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT 04/21/1981
K811212 IMMUNO ASSAY CORP. DIGOXIN (RIA) KIT 05/21/1981
K852343 M NOBIRD, INC. DIG RADIOIMMUNOASSAY TEST SYSTEM 07/09/1985
K781495 NEW ENGLAND NUCLEAR RIANEN ASSAY SYSTEM, 125I KIT 09/14/1978
K852291 NUCLEAR DIAGNOSTICS, INC. TIPSEP DIGOXIN RIA 06/25/1985
K781834 WIEN LABORATORIES, INC. TEST SET, 125 I-DIGOXIN 01/03/1979


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