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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease and glutamic dehydrogenase, urea nitrogen
510(k) Number K993925
Device Name WAKO L-TYPE UN TEST
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received11/18/1999
Decision Date 04/03/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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