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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name diazonium colorimetry, urobilinogen (urinary, non-quant.)
510(k) Number K873366
Device Name WAKO(TM) PRETEST 5A
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 Number862.1785
Classification Product Code
CDM  
Date Received08/21/1987
Decision Date 01/21/1988
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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