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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Primary
510(k) Number K994114
Device Name DIMENSION TOTAL IRON BINDING CAPACITY (IBCT) CALIBRATOR
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact ROBIN O NORRIS
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact ROBIN O NORRIS
Regulation Number862.1150
Classification Product Code
JIS  
Date Received12/06/1999
Decision Date 01/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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