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HOME HEALTH US INCORPORATED

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30211862263021186226HOME HEALTH US INCORPORATED1Y2026-01-017672 15th St E Sarasota FL US 34243

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2991461795170910K790282ELDONCARDKSZ1979-05-04
2991461690106966K242721Upper Arm Electronic Blood Pressure Monitor (FC-BP103, FC-BP106, FC-BP113, FC-BP120, FC-BP121, FC-BP130, FC-BP131)DXN2024-10-04
2991461345065484K240698Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG2024-05-10
2991461365275109K240643MissLan® Early Detection Pregnancy Test Strip; MissLan® Early Detection Pregnancy Test Cassette; MissLan® Early Detection Pregnancy Test MidstreamLCX2024-06-21
2991461757803921K230043Insulin Pen NeedleFMI2023-09-20
2991461444682337K222472Lancing System, Sterile Lancet for Single Use, Lancing DeviceQRL2022-11-30
2991461893439055K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)DKZ2019-03-27
2991461753800922K181239Infrared Forehead Thermometer, Infrared Ear/Forehead ThermometerFLL2018-10-29
2991461130226188K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL2018-05-23
2991461912782242K110309FOB ONE STEP RAPID TESTKHE2011-09-14
2991461073585993
2991461115265582
2991461339690191
2991461378134216
2991461386756221
2991461393299226
2991461482288362
2991461526995509
2991461528677452
2991461776824372
2991461823284693
2991461835383126
2991461887629325
2991461911893099
2991461967708170

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN12024-10-04
LCX12024-06-21
DJG12024-05-10
FMI12023-09-20
QRL12022-11-30
DKZ12019-03-27
FLL12018-10-29
JIL12018-05-23
KHE12011-09-14
KSZ11979-05-04