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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
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