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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 K061249
Device Name AXSYM DIGOXIN III
Applicant
ABBOTT LABORATORIES
D 9VA, BLDG. AP6C-2
100 ABBOTT PARK RD
ABBOTT PARK,  IL  60064 -3500
Applicant Contact KENTON SMITH
Correspondent
ABBOTT LABORATORIES
D 9VA, BLDG. AP6C-2
100 ABBOTT PARK RD
ABBOTT PARK,  IL  60064 -3500
Correspondent Contact KENTON SMITH
Regulation Number862.3320
Classification Product Code
KXT  
Subsequent Product Codes
JIT   JJX  
Date Received05/04/2006
Decision Date 06/02/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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