Alinity C ICT Sample Diluent

Electrode, Ion-specific, Chloride

Abbott Laboratories

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Alinity C Ict Sample Diluent.

Pre-market Notification Details

Device IDK170320
510k NumberK170320
Device Name:Alinity C ICT Sample Diluent
ClassificationElectrode, Ion-specific, Chloride
Applicant Abbott Laboratories Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road Abbott Park,  IL  60064
ContactZaman Khan
CorrespondentZaman Khan
Abbott Laboratories Dept. 09AA, Bldg CP01-3, 100 Abbott Park Road Abbott Park,  IL  60064
Product CodeCGZ  
Subsequent Product CodeCEM
Subsequent Product CodeJGS
CFR Regulation Number862.1170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-02-01
Decision Date2017-10-24
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.