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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 K864743
Device Name BIURET (COLORIMETRIC), TOTAL PROTEIN
Applicant
Tech-Co, Inc.
4378 Reilly
Troy,  MI  48098
Applicant Contact HAPPY CHEN
Correspondent
Tech-Co, Inc.
4378 Reilly
Troy,  MI  48098
Correspondent Contact HAPPY CHEN
Regulation Number862.1635
Classification Product Code
CEK  
Date Received12/04/1986
Decision Date 01/13/1987
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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