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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 K761217
Device Name AUTO TOTAL PROTEIN
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 Received12/07/1976
Decision Date 12/21/1976
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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