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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bromcresol Purple Dye-Binding, Albumin
510(k) Number K832632
Device Name ALBUMIN PROCEDURE BCP
Applicant
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Sandare Chemical Co., Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1035
Classification Product Code
CJW  
Date Received08/04/1983
Decision Date 09/12/1983
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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