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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 K781423
Device Name DUAL COMPONENT STANDARDS
Applicant
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Correspondent
ABBOTT LABORATORIES
ONE ABBOTT PARK RD.
ABBOTT PARK,  IL  60064 -3500
Regulation Number862.1150
Classification Product Code
JIT  
Date Received08/17/1978
Decision Date 08/31/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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