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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K990825
Device Name REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE
Applicant
DADE BEHRING, INC.
P.O. BOX 6101
ROUTE 896, GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Applicant Contact LORRAINE PIESTRAK
Correspondent
DADE BEHRING, INC.
P.O. BOX 6101
ROUTE 896, GLASGOW BLDG. 500
NEWARK,  DE  19714 -6101
Correspondent Contact LORRAINE PIESTRAK
Regulation Number866.5270
Classification Product Code
DCN  
Date Received03/12/1999
Decision Date 04/16/1999
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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