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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K011035
Device Name DIMENSION DRUG CALIBRATOR, MODEL DC22B
Original Applicant
DADE BEHRING, INC.
glasgow business community
bldg 500, ms 514 p.o.box 6101
newark,  DE  19714 -6101
Original Contact richard m vaught
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/05/2001
Decision Date 06/14/2001
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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