ION 2 REAGENT KI

Electrode, Ion Specific, Potassium

HI CHEM, INC.

The following data is part of a premarket notification filed by Hi Chem, Inc. with the FDA for Ion 2 Reagent Ki.

Pre-market Notification Details

Device IDK851350
510k NumberK851350
Device Name:ION 2 REAGENT KI
ClassificationElectrode, Ion Specific, Potassium
Applicant HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
ContactWynn Stocking
CorrespondentWynn Stocking
HI CHEM, INC. 231 N. PUENTE ST. P.O. BOX 1599 Brea,  CA  92621
Product CodeCEM  
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-04
Decision Date1985-04-29

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