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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 K983693
Device Name DIMENSIONS (R) RXL CARDIAC TROPONIN I CALIBRATOR
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/21/1998
Decision Date 11/04/1998
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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