TECHNICON ASSIST POTASSIUM

Tetraphenyl Borate, Colorimetry, Potassium

TECHNICON INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Technicon Instruments Corp. with the FDA for Technicon Assist Potassium.

Pre-market Notification Details

Device IDK883585
510k NumberK883585
Device Name:TECHNICON ASSIST POTASSIUM
ClassificationTetraphenyl Borate, Colorimetry, Potassium
Applicant TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
ContactLeonard A Dwarica
CorrespondentLeonard A Dwarica
TECHNICON INSTRUMENTS CORP. 511 BENEDICT AVE. Tarrytown,  NY  10591
Product CodeCEJ  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-23
Decision Date1988-11-29

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