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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Multi-Analyte Mixture
510(k) Number K850396
Device Name ROCHE STANDARDS FOR CHLORIDE & CO2
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 Number862.1150
Classification Product Code
JIX  
Date Received02/01/1985
Decision Date 02/27/1985
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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