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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 K921412
Device Name MICROPROTEIN REAGENT SET
Applicant
Sterling Diagnostics, Inc.
6226 Product Dr.
Sterling Heights,  MI  48312
Applicant Contact DAVID L CALLENDER
Correspondent
Sterling Diagnostics, Inc.
6226 Product Dr.
Sterling Heights,  MI  48312
Correspondent Contact DAVID L CALLENDER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received03/24/1992
Decision Date 01/21/1993
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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