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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Igm, Antigen, Antiserum, Control
510(k) Number K880828
Device Name WAKO(TM) IGM-HA DIRECT
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 Number866.5550
Classification Product Code
DFT  
Date Received03/01/1988
Decision Date 03/25/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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