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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 K843108
Device Name SYSTEMATE ALBUMIN
Applicant
Em Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Em Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CIX  
Date Received08/07/1984
Decision Date 08/27/1984
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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