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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 K915380
Device Name MICROPROTEIN-PR
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact WILLIAM GILBERT
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact WILLIAM GILBERT
Regulation Number862.1635
Classification Product Code
CEK  
Date Received11/29/1991
Decision Date 02/18/1992
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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