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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 K842847
Device Name WAKO AUTOMATED REAGENTS FOR HITACHI 705
Applicant
Wako Chemicals USA, Inc.
12200 Ford Rd.
Suite 212
Dallas,  TX  75234
Applicant Contact HIROYUKI HAYASHI
Correspondent
Wako Chemicals USA, Inc.
12200 Ford Rd.
Suite 212
Dallas,  TX  75234
Correspondent Contact HIROYUKI HAYASHI
Regulation Number862.1035
Classification Product Code
CJW  
Date Received07/20/1984
Decision Date 12/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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