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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 K853049
Device Name ALBUMIN REAGENT FOR ASTRA 8 AUTO STAT/ROUT ANALYZE
Applicant
Simmler, Inc.
3755 Forest Park Ave.
St. Louis,  MO  63108
Applicant Contact R. M BOEDEKER
Correspondent
Simmler, Inc.
3755 Forest Park Ave.
St. Louis,  MO  63108
Correspondent Contact R. M BOEDEKER
Regulation Number862.1035
Classification Product Code
CIX  
Date Received07/19/1985
Decision Date 08/02/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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