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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 K854553
Device Name TOTAL PROTEIN
Applicant
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Applicant Contact LINDA M CHINN
Correspondent
AMERICAN MONITOR CORP.
P.O. BOX 68505
INDIANAPOLIS,  IN  46268
Correspondent Contact LINDA M CHINN
Regulation Number862.1635
Classification Product Code
CEK  
Date Received11/13/1985
Decision Date 11/25/1985
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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