SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+

Electrode, Ion Specific, Potassium

Diamond Diagnostics Inc.

The following data is part of a premarket notification filed by Diamond Diagnostics Inc. with the FDA for Smartlyte® Plus Electrolyte Analyzer Na+/k+/cl-/ca++/li+.

Pre-market Notification Details

Device IDK200544
510k NumberK200544
Device Name:SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+
ClassificationElectrode, Ion Specific, Potassium
Applicant Diamond Diagnostics Inc. 333 Fiske Street Holliston,  MA  01746
ContactKathy Fisher
CorrespondentKathy Fisher
Diamond Diagnostics Inc. 333 Fiske Street Holliston,  MA  01746
Product CodeCEM  
Subsequent Product CodeCGZ
Subsequent Product CodeJFP
Subsequent Product CodeJGS
Subsequent Product CodeJIH
Subsequent Product CodeJJE
CFR Regulation Number862.1600 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-03
Decision Date2020-10-01

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