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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 K802157
Device Name BCG REAGENT SERUM ALBUMIN W/TECHNICON
Applicant
PANMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PANMED, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CIX  
Date Received09/08/1980
Decision Date 10/10/1980
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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