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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 K963062
Device Name IMMAGE SYSTEM DIGOXIN (DIG) REAGENT/BECKMAN DRUG CALIBRATOR 2
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Applicant Contact MARGIE GEORGE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
M.S. W-351
Brea,  CA  92621
Correspondent Contact MARGIE GEORGE
Regulation Number862.3320
Classification Product Code
KXT  
Date Received08/07/1996
Decision Date 12/13/1996
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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