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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C3, Antigen, Antiserum, Control
510(k) Number K994296
Device Name DIMENSION C3 FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Applicant Contact RICHARD M VAUGHT
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Correspondent Contact RICHARD M VAUGHT
Regulation Number866.5240
Classification Product Code
CZW  
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
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