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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Complement C9, Antigen, Antiserum, Control
510(k) Number K954145
Device Name WAKO AUTOKIT CH50
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 Number866.5240
Classification Product Code
DAE  
Date Received09/05/1995
Decision Date 12/18/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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