FDA 510(k) Applications for Medical Device Product Code "DKA"
(Antiserum, Digoxin)

FDA 510(k) Number Applicant Device Name Decision Date
K934003 BAXTER DIAGNOSTICS, INC. STRATUS DIGOXIN FLOUROMETRIC ENZYME IMMUNOASSAY 11/22/1994
K780498 CLINICAL BIORESEARCH CBR-DIGOXIN ANTISERUM 04/05/1978
K780316 PCL-RIA, INC. RABBIT ANTIBODY TO DIGOXIN 03/17/1978


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