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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nadh oxidation/nad reduction, ast/sgot
510(k) Number K864813
Device Name WAKO (TM) AUTOKIT GOT TEST
Original Applicant
WAKO CHEMICALS, USA, INC.
12300 ford rd.
suite 130
dallas,  TX  75234
Original Contact toshihiko doa
Regulation Number862.1100
Classification Product Code
CIT  
Date Received12/09/1986
Decision Date 02/13/1987
Decision substantially equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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