ULTRA LYTE SODIUM REAGENT KIT

Electrode, Ion Specific, Sodium

ULTRA QUEST DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Ultra Quest Diagnostics, Inc. with the FDA for Ultra Lyte Sodium Reagent Kit.

Pre-market Notification Details

Device IDK843453
510k NumberK843453
Device Name:ULTRA LYTE SODIUM REAGENT KIT
ClassificationElectrode, Ion Specific, Sodium
Applicant ULTRA QUEST DIAGNOSTICS, INC. 1404 NORTH MAIN STREET Indianapolis ,  IN  46224 -
ContactBrady
CorrespondentBrady
ULTRA QUEST DIAGNOSTICS, INC. 1404 NORTH MAIN STREET Indianapolis ,  IN  46224 -
Product CodeJGS  
CFR Regulation Number862.1665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-05
Decision Date1984-11-27

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