FDA.reportPublic FDA data

Kingsway

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30131672213013167221KINGSWAY PHARMACEUTICALS DBA NFI, LLC1Y2026-01-01636 Shelby Street Suite 300 Bristol TN US 37620

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2110372022008459K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCX2024-06-21
2110371995978111K231045Healgen URS Test StripsLJX2023-06-16
2110371155722077K230038MissLan® Pregnancy Rapid Test (Strip), MissLan® Pregnancy Rapid Test (Midstream)LCX2023-02-28
2110371785328694K222305MissLan™ Digital Pregnancy Rapid TestLCX2022-11-30
2110371993159556K180771Acro HCG Pregnancy Rapid TestLCX2018-05-18
2110371422312028
2110371507333826
2110371873636093

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
LCX42024-06-21
LJX12023-06-16

NDC#

PBZ OTC

Kingsway Pharmaceuticals dba NFI, LLC

Tripelennamine HCl 1%

Lidocare

Kingsway Pharmaceuticals dba NFI, LLC

4% Lidocaine