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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mercuric Thiocyanate, Colorimetry, Chloride
510(k) Number K850334
Device Name ROCHE REAGENT FOR CHLORIDE, FOR THE COBAS
Applicant
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Applicant Contact GRIFFIN FITZGERALD
Correspondent
Roche Diagnostic Systems, Inc.
Div. Of Hoffmann-La Roche, Inc
Nutley,  NJ  07110
Correspondent Contact GRIFFIN FITZGERALD
Regulation Number862.1170
Classification Product Code
CHJ  
Date Received01/28/1985
Decision Date 03/14/1985
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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