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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name radioimmunoassay, digoxin (125-i), rabbit antibody, solid phase sep.
510(k) Number K881679
Device Name CIBA CORNING MAGIC LITE DIGOXIN IMMUNOASSAY
Applicant
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
e. walpole,  MA  02032
Applicant Contact william j pignato
Correspondent
CIBA CORNING DIAGNOSTICS CORP.
333 CONEY ST.
e. walpole,  MA  02032
Correspondent Contact william j pignato
Regulation Number862.3320
Classification Product Code
DON  
Date Received04/19/1988
Decision Date 07/08/1988
Decision substantially equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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