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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 K875070
Device Name ALBUMIN, BROMCRESOL GREEN DYE-BINDING
Applicant
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Applicant Contact HAPPY CHEN
Correspondent
Tech-Co, Inc.
24111 Beverly
Oak Park,  MI  48237
Correspondent Contact HAPPY CHEN
Regulation Number862.1035
Classification Product Code
CIX  
Date Received12/09/1987
Decision Date 01/11/1988
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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