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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, Centrifugal, For Clinical Use
510(k) Number K885203
Device Name TECHNICON DAX(TM) SYSTEM
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact A DWARICA
Regulation Number862.2140
Classification Product Code
JJG  
Date Received12/19/1988
Decision Date 03/28/1989
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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