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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K040918
Device Name WAKO LIPID CONTROL, LEVEL 1 AND LEVEL 2
Applicant
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Applicant Contact LORI CREASY
Correspondent
WAKO CHEMICALS, USA, INC.
1600 BELLWOOD ROAD
RICHMOND,  VA  23237
Correspondent Contact LORI CREASY
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/08/2004
Decision Date 05/17/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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