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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 K983151
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM DIGOXIN (DIG) REAGENT
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact RICHARD T ROSS
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact RICHARD T ROSS
Regulation Number862.3320
Classification Product Code
KXT  
Date Received09/09/1998
Decision Date 11/05/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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