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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 K983850
Device Name DIMENSION AHDL CALIBRATOR
Applicant
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Applicant Contact REBECCA S AYASH
Correspondent
DADE BEHRING, INC.
BLDG. 500 MAIL BOX 514
P.O. BOX 6101
NEWARK,  DE  19714 -6101
Correspondent Contact REBECCA S AYASH
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/30/1998
Decision Date 11/18/1998
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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