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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 K853244
Device Name TOTAL PROTEIN REAGENT FOR ASTRA 8 STAT/ROU ANALYZE
Applicant
SIMMLER, INC.
3755 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Applicant Contact BOEDEKER
Correspondent
SIMMLER, INC.
3755 FOREST PARK AVE.
ST. LOUIS,  MO  63108
Correspondent Contact BOEDEKER
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/01/1985
Decision Date 08/12/1985
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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