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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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