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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 K983548
Device Name FERRITIN CALIBRATOR
Applicant
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Applicant Contact CATHY P CRAFT
Correspondent
Dade Behring, Inc.
Rt. 896, Glascow Bldg. 500
Newark,  DE  19714
Correspondent Contact CATHY P CRAFT
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/09/1998
Decision Date 10/27/1998
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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