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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 K920531
Device Name WAKO AUTOKIT MICRO TP
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact ED ZIOR
Correspondent
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact ED ZIOR
Regulation Number862.1635
Classification Product Code
CEK  
Date Received02/05/1992
Decision Date 07/14/1992
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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