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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipoprotein, Low-Density, Antigen, Antiserum, Control
510(k) Number K001920
Device Name WAKO AUTOKIT LP(A)/ RA,500/1000,
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 Number866.5600
Classification Product Code
DFC  
Date Received06/23/2000
Decision Date 07/23/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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