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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 K994291
Device Name DIMENSION SPECIAL PROTEIN CALIBRATOR
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
ROUTE 896, GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Applicant Contact RICHARD M VAUGHT
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
ROUTE 896, GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Correspondent Contact RICHARD M VAUGHT
Regulation Number862.1150
Classification Product Code
JIT  
Date Received12/21/1999
Decision Date 03/01/2000
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
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