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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name enzymatic method, ammonia
510(k) Number K913124
Device Name ROCHE REAGENT FOR AMMONIA
Applicant
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
montclair,  NJ  07042
Applicant Contact carol l krieger
Correspondent
ROCHE DIAGNOSTIC SYSTEMS, INC.
ONE SUNSET AVE.
montclair,  NJ  07042
Correspondent Contact carol l krieger
Regulation Number862.1065
Classification Product Code
JIF  
Date Received07/15/1991
Decision Date 08/12/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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