FDA.reportPublic FDA data

Robert James

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30126806433012680643Robert James1N2026-01-017153 montevista dr SE Auburn WA US 98092

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2350881130478281K251795Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753)DXN2025-10-09
2350881617545950K240242HCG Home Use Pregnancy Test Strip (Colloidal Gold), HCG Home Use Pregnancy Test Cassette (Colloidal Gold), HCG Home Use Pregnancy Test Midstream (Colloidal Gold)LCX2024-10-11
2350881615129531K230566Arm-type Fully Automatic Digital Blood Pressure Monitor, Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2023-08-25
2350881014135124K221857Aneroid sphygmomanometer with stethoscope, QL-50, Aneroid sphygmomanometer, QL-20, Aneroid sphygmomanometer, QL-201DXQ2022-10-13
2350881258691781K221368Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2022-06-09
2350881442152803K220673Sterile Silver Alginate Wound DressingFRO2023-03-16
2350881146383868K213189Wrist-type Fully Automatic Digital Blood Pressure MonitorDXN2022-03-01
2350881766105749K211084Aneroid Sphygmomanometer, Aneroid Sphygmomanometer with stethoscopeDXQ2021-10-19
2350881582921497K193259Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometerDXQ2020-07-02
2350881170609601K192666Promisemed Blood Lancet, VeriFine Safety Lancet, VeriFine Mini-Safety LancetFMK2019-12-02
2350881288236600K192568Jiajian Self-Adhesive ElectrodeGXY2021-02-03
2350881102921115K190886Non-invasive blood pressure measurement systemsDXN2019-07-29
2350881265273186K173024Non-invasive blood pressure measurement systemsDXN2018-08-22
2350881697075539K170866Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579DXN2018-02-21
2350881390961496K170666The Wrist-Type Fully Automatic Digital Blood Pressure MonitorsDXN2017-11-22
2350881094495991K161950Common Type Insulin Pen Needle, Safety Type Insulin Pen NeedleFMI2017-05-11
2350881068393305K152648Ennova Self-adhesive ElectrodeGXY2016-02-18
2350881596400476K132588ADHESIVE ELECTRODESGXY2013-11-22
2350881588796490K131463WRIST AUTOMATIC BLOOD PRESSURE MONITORDXN2013-07-08
2350881873883205K130925AUTOMATIC BLOOD PRESSURE MONITORDXN2013-09-12
2350881893849774K102792DISPOSABLE BLOOD PRESSURE CUFDXQ2011-01-26
2350881627675853K102624AVITA WRIST TYPE BLOOD PRESSURE MONITORDXN2010-12-16
2350881079441043K090198JIAJIAN SELF-ADHESIVE ELECTRODEGXY2009-06-23
2350881112288324K090014CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPEDXQ2009-04-09
2350881641774027K053236DAVID PREGNANCY TEST (MIDSTREAM)LCX2006-07-18
2350881016751602
2350881062884359
2350881141192202
2350881155839505
2350881221413450
2350881281005895
2350881394235727
2350881520917813
2350881558131764
2350881619592955
2350881742996045
2350881801682233
2350881879859363
2350881889035066
2350881898212074
2350881933522270
2350881943668184
2350882041064246
2350882071831111
2350881035460718
2350881214572021
2350881365346746
2350881450261851
2350881471492930

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DXN142025-10-09
DXQ62022-10-13
GXY42021-02-03
LCX32024-10-11
FMK22022-06-09
FMI22017-05-11
FRO12023-03-16