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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 K020980
Device Name DIMENSION TPSA CALIBRATOR, MODEL #RC459
Applicant
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Applicant Contact GEORGE M PLUMMER
Correspondent
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Correspondent Contact GEORGE M PLUMMER
Regulation Number862.1150
Classification Product Code
JIT  
Date Received03/26/2002
Decision Date 06/21/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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