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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 K880313
Device Name WAKO(TM) AUTOKIT ALBUMIN
Applicant
Wako Chemicals USA, Inc.
12300 Ford Rd.
Suite 130
Dallas,  TX  75234
Applicant Contact TOSHIHIKO ODA
Correspondent
Wako Chemicals USA, Inc.
12300 Ford Rd.
Suite 130
Dallas,  TX  75234
Correspondent Contact TOSHIHIKO ODA
Regulation Number862.1035
Classification Product Code
CIX  
Date Received01/25/1988
Decision Date 03/24/1988
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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