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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Biuret (Colorimetric), Total Protein
510(k) Number K880312
Device Name WAKO(TM) AUTOKIT TOTAL PROTEIN
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 Number862.1635
Classification Product Code
CEK  
Date Received01/25/1988
Decision Date 03/24/1988
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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