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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 K853404
Device Name QCA POTASSIUM TEST KIT
Applicant
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Applicant Contact RUSSELL ARNSBERGER
Correspondent
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC
MACK CENTRE DR.
P.O.BOX 2224
PARAMUS,  NJ  07652
Correspondent Contact RUSSELL ARNSBERGER
Regulation Number862.1600
Classification Product Code
CEJ  
Date Received08/12/1985
Decision Date 08/23/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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