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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name electrode, ion specific, potassium
510(k) Number K895664
Device Name TECHNICON DAX SYSTEM - POTASSIUM (ISE) METHOD
Applicant
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
TECHNICON INSTRUMENTS CORP.
511 BENEDICT AVE.
TARRYTOWN,  NY  10591
Correspondent Contact LEONARD A DWARICA
Regulation Number862.1600
Classification Product Code
CEM  
Date Received09/20/1989
Decision Date 11/14/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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