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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Digoxin
510(k) Number K893843
Device Name EZ-BEAD DIGOXIN EIA KIT
Applicant
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Applicant Contact FRANCIS CAPITANIO
Correspondent
Immunotech Corp.
90 Windom St.
P.O. Box 860
Boston,  MA  02134
Correspondent Contact FRANCIS CAPITANIO
Regulation Number862.3320
Classification Product Code
KXT  
Date Received05/25/1989
Decision Date 09/28/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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