FDA.reportPublic FDA data

CorDx, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30318233593031823359CorDx, Inc.1N2026-01-015900 Windward Pkwy Alpharetta GA US 30005
30344055083034405508CORDX LABS, INC.1Y2026-01-015900 Windward Pkwy Ste 335 Alpharetta GA US 30005

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3302751127985248K240728CorDx Tyfast COVID-19 Ag Rapid Test; CorDx COVID-19 Ag TestQYT2024-06-21
3348441074081260K222994Arm Blood Pressure Monitor, models AOJ-33A and AOJ-33BDXN2023-07-26
3348441022929187K221798Finger Pulse Oximeter, Model: X1906PDQA2023-05-04
3348441977989977K210564Infrared ThermometerFLL2022-01-07
3348441085315371K210563Arm Blood Pressure MonitorDXN2021-10-15
3302751430092745K190412CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy CupNGL2019-03-21
3302751085009350K152590ACCU NEWS Drug Screening Test Card/Urine CupDKZ2016-04-15
3302751646134385K150063One Step hCG Pregnancy TestLCX2015-10-02
3348441022929187
3302751060809471
3348441289082843
3302751379043263
3302751526174219
3302751895018991

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN22023-07-26
QYT12024-06-21
DQA12023-05-04
FLL12022-01-07
NGL12019-03-21
DKZ12016-04-15
LCX12015-10-02

PMN#