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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K871759
Device Name G-GT STANDARD CALIBRATOR
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 Number862.1150
Classification Product Code
JIT  
Date Received05/05/1987
Decision Date 09/29/1987
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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