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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Berthelot Indophenol, Urea Nitrogen
510(k) Number K896845
Device Name RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
Applicant
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Applicant Contact J SHRAWDER,PHD
Correspondent
Reagents Applications, Inc.
8225 Mercury Ct.
San Diego,  CA  92111
Correspondent Contact J SHRAWDER,PHD
Regulation Number862.1770
Classification Product Code
CDL  
Date Received12/06/1989
Decision Date 02/16/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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