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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transferrin, Antigen, Antiserum, Control
510(k) Number K993162
Device Name WAKO TRANSFERRIN, TRANSFERRIN CALIBRATOR
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 Number866.5880
Classification Product Code
DDG  
Date Received09/22/1999
Decision Date 11/12/1999
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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