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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 K885226
Device Name TECHNICON AXON(TM) SYSTEM
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact A DWARICA
Regulation Number862.2160
Classification Product Code
JJE  
Date Received12/20/1988
Decision Date 02/17/1989
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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