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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Green Dye-Binding, Albumin
510(k) Number K874049
Device Name MULTICHEM ALBUMIN REAGENT S0902
Applicant
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Applicant Contact CRIDER, PHD
Correspondent
Simmler, Inc.
Post Office Box 25179
St. Louis,  MO  63125
Correspondent Contact CRIDER, PHD
Regulation Number862.1035
Classification Product Code
CIX  
Date Received10/05/1987
Decision Date 10/29/1987
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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