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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C4, Antigen, Antiserum, Control
510(k) Number K994293
Device Name DIMENSION C4 FLEX REAGENT CARTRIDGE
Applicant
Dade Behring, Inc.
P.O. Box 6101
Rte. 896, Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact RICHARD M VAUGHT
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Rte. 896, Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact RICHARD M VAUGHT
Regulation Number866.5240
Classification Product Code
DBI  
Date Received12/21/1999
Decision Date 03/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
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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