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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Turbidimetric Method, Lipoproteins
510(k) Number K952615
Device Name WAKO AUTOKIT APO A1
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 Number862.1475
Classification Product Code
JHN  
Date Received06/06/1995
Decision Date 09/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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