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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K823579
Device Name COBAS REAGENT FOR TOTAL PROTEIN
Applicant
Hoffmann-La Roche, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Hoffmann-La Roche, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1635
Classification Product Code
CEK  
Date Received12/06/1982
Decision Date 01/07/1983
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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