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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Iga, Antigen, Antiserum, Control
510(k) Number K993927
Device Name WAKO IGA II-HA, IMMUNOGLOBULIN CALIBRATOR SET, IMMUNOGLOBULIN STANDRAD
Applicant
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Applicant Contact TONYA MALLORY
Correspondent
Wako Chemicals USA, Inc.
1600 Bellwood Rd.
Richmond,  VA  23237
Correspondent Contact TONYA MALLORY
Regulation Number866.5510
Classification Product Code
CZP  
Date Received11/18/1999
Decision Date 01/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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