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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Coulometric Method, Carbon-Dioxide
510(k) Number K911838
Device Name ROCHE REAGENT FOR C02
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 Number862.1160
Classification Product Code
CHS  
Date Received04/25/1991
Decision Date 07/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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