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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name tetraphenyl borate, colorimetry, potassium
510(k) Number K883586
Device Name TECHNICON RA-100 SYSTEM POTASSIUM
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
CEJ  
Date Received08/23/1988
Decision Date 11/29/1988
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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