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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 K772155
Device Name ULTRACHEM TOTAL PROTEIN, #64974
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 Received11/16/1977
Decision Date 12/06/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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