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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 K863486
Device Name POTASSIUM TEST
Applicant
SCLAVO, INC.
5 MANSARD COURT
WAYNE,  NJ  07470
Applicant Contact KING, PH.D.
Correspondent
SCLAVO, INC.
5 MANSARD COURT
WAYNE,  NJ  07470
Correspondent Contact KING, PH.D.
Regulation Number862.1600
Classification Product Code
CEJ  
Date Received09/09/1986
Decision Date 09/29/1986
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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