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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 K863301
Device Name DEMAND TOTAL PROTEIN
Applicant
Cooper Biomedical, Inc.
One Technology Court
Malvern,  PA  19355
Applicant Contact BREWSTER, PHD
Correspondent
Cooper Biomedical, Inc.
One Technology Court
Malvern,  PA  19355
Correspondent Contact BREWSTER, PHD
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/25/1986
Decision Date 09/26/1986
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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