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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 K771926
Device Name TOTAL PROTEIN SET, ITEM NO. 64010
Applicant
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Harleco
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1635
Classification Product Code
CEK  
Date Received10/14/1977
Decision Date 11/11/1977
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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