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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 K771476
Device Name MULTISTAT III TOTAL PROTEIN TEST
Applicant
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Instrumentation Laboratory CO
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/04/1977
Decision Date 09/12/1977
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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