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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
510(k) Number K853391
Device Name MULTIPURPOSE IMMUNOCHEMISTRY SYS-LA-2000
Applicant
Eiken Chemical Co., Inc.
2004 Walnut Ave.
Venice,  CA  90291
Applicant Contact JAMES F GODFREY
Correspondent
Eiken Chemical Co., Inc.
2004 Walnut Ave.
Venice,  CA  90291
Correspondent Contact JAMES F GODFREY
Regulation Number862.2160
Classification Product Code
JJE  
Date Received08/13/1985
Decision Date 10/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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