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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K863920
Device Name WAKO(TM) ZN TEST
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
Date Received10/08/1986
Decision Date 09/16/1987
Decision Substantially Equivalent (SESE)
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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