POTASSIUM TEST

Tetraphenyl Borate, Colorimetry, Potassium

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Potassium Test.

Pre-market Notification Details

Device IDK863486
510k NumberK863486
Device Name:POTASSIUM TEST
ClassificationTetraphenyl Borate, Colorimetry, Potassium
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactKing, Ph.d.
CorrespondentKing, Ph.d.
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeCEJ  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-09-09
Decision Date1986-09-29

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