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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Method, Nephelometric, Immunoglobulins (G, A, M)
510(k) Number K864342
Device Name MULTIPURPOSE IMMUNOCHEMISTRY SYSTEM LA-2000 LATEX
Applicant
Eiken Chemical Co., Inc.
2004 Walnut Ave.
Venice,  CA  90291
Applicant Contact JAMES GODFREY
Correspondent
Eiken Chemical Co., Inc.
2004 Walnut Ave.
Venice,  CA  90291
Correspondent Contact JAMES GODFREY
Regulation Number866.5510
Classification Product Code
CFN  
Date Received11/04/1986
Decision Date 12/01/1986
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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