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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 K860684
Device Name SANDARE BCG ALBUMIN PROCEDURE
Applicant
SANDARE CHEMICAL CO., INC.
P.O. BOX 3028
DESOTO,  TX  75115
Applicant Contact JAMES L SANDERS
Correspondent
SANDARE CHEMICAL CO., INC.
P.O. BOX 3028
DESOTO,  TX  75115
Correspondent Contact JAMES L SANDERS
Regulation Number862.1035
Classification Product Code
CIX  
Date Received02/25/1986
Decision Date 03/17/1986
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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