FDA.reportPublic FDA data

iXensor USA Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30175487993017548799iXensor USA Inc1N2026-01-0129122 Rancho Viejo Rd Ste 212 San Juan Capistrano CA US 92675

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2819591017936864K192369PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP2019-10-29
2819591593583494K181915PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test KitLCP2019-04-12
2819591991260008K163087PixoTest Blood Glucose Monitoring SystemNBW2017-11-02
2819591290123714

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCP22019-10-29
NBW12017-11-02