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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name O-Phthalaldehyde, Urea Nitrogen
510(k) Number K904049
Device Name ROCHE COBAS READY RENAL PROFILE REAGENT STRIP
Applicant
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Applicant Contact CAROL KRIEGER
Correspondent
Roche Diagnostic Systems, Inc.
One Sunset Ave.
Montclair,  NJ  07042
Correspondent Contact CAROL KRIEGER
Regulation Number862.1770
Classification Product Code
JGZ  
Date Received09/04/1990
Decision Date 10/12/1990
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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