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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calibrator, secondary
510(k) Number K053330
Device Name ARCHITECT B12 CALIBRATORS
Applicant
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -6095
Applicant Contact MARGARET PROCHNIAK
Correspondent
ABBOTT LABORATORIES
100 ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -6095
Correspondent Contact MARGARET PROCHNIAK
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/01/2005
Decision Date 12/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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