QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test
Osang, LLC
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3004146366 | 3004146366 | OSANG Healthcare CO., LTD. | 1 | N | 2026-01-01 | 132, Anyangcheondong-ro DONGAN-GU ANYANG Gyeonggi KR 14040 |
| 3020885868 | 3020885868 | OSANG LLC | 1 | N | 2026-01-01 | 625 Fair Oaks Ave Ste 360 S Pasadena CA US 91030 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00793150629787 | Oh’Care Lite Blood Glucose Test strips - Blood Glucose Test strips | 800-925-2949 | support@ijdream.com |
| 08809115905369 | OKRA Glucose Test Strip(25T) - IGM-1003A | 1-833-977-1339 | support@okra.care |
| 08809115905697 | OKRA Glucose Test Strip Refill kit - Blood Glucose Test strips Refill kit | 1-833-977-1339 | Support@okra.care |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 76247 | 1594017082 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | SCA | 2025-01-13 |
| 297459 | 1594017082 | K243262 | QuickFinder COVID-19/Flu Antigen Self Test / QuickFinder COVID-19/Flu Antigen Pro Test | SCA | 2025-01-13 |
| 297459 | 1993406432 | K241313 | OHC COVID-19 Antigen Self Test | QYT | 2025-05-30 |
| 76247 | 1993406432 | K241313 | OHC COVID-19 Antigen Self Test | QYT | 2025-05-30 |
| 76247 | 1324520890 | K221970 | Lancing device | QRL | 2022-08-30 |
| 76247 | 2062311603 | K221507 | Disposable Blood Lancet | QRK | 2022-08-31 |
| 76247 | 1954336225 | K203562 | Finetest Lite Blood Glucose Monitoring System | NBW | 2021-07-13 |
| 297459 | 1696468619 | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | NBW | 2020-10-16 |
| 76247 | 1696468619 | K201396 | Finetest Lite Smart Blood Glucose Monitoring System | NBW | 2020-10-16 |
| 297459 | 1099918859 | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | NBW | 2018-09-19 |
| 76247 | 1099918859 | K182286 | Oh'Care Lite Smart Blood Glucose Monitoring System | NBW | 2018-09-19 |
| 76247 | 1934219630 | K160365 | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System | NBW | 2016-09-28 |
| 76247 | 1995885052 | K141750 | HEMOCUE HBA1C 501 GLYCOSYLATED HEMOGLOBIN MONITORING SYSTEM | LCP | 2014-07-24 |
| 76247 | 1318559856 | K132966 | GLUNEO LITE GLUCOSE MONITORING SYSTEM, GLUNEO LITE PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-12-05 |
| 76247 | 1628388835 | K130295 | LIPIDPRO LIPID PROFILE AND GLUCOSE MEASURING SYSTEM, LIPIDPRO PROFESSIONAL LIPID PROFILE AND GLUCOSE MEASURING SYSTEM. | NBW | 2013-06-21 |
| 76247 | 2065334492 | K130181 | GLUNEO BLOOD GLUCOSE MONITORING SYSTEM, AND PROFESSIONAL BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2013-07-31 |
| 297459 | 1164546508 | K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-07-13 |
| 76247 | 1164546508 | K113192 | HEALTHPRO BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2012-07-13 |
| 76247 | 1883882919 | K110435 | EASYGLUCO PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2011-09-21 |
| 76247 | 1098750785 | K103021 | ELEMENT PLUS BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2011-11-04 |
| 76247 | 1420304919 | K082275 | CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 | LCP | 2010-01-14 |
| 76247 | 2049484297 | K082201 | G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A | NBW | 2009-02-20 |
| 76247 | 1227492724 | K081703 | MYGLUCOHEALTH GLUCOSE MONITORING SYSTEMS | NBW | 2009-01-08 |
| 76247 | 1868495055 | K061431 | EASYGLUCO, MODEL IGM-0002 G2 | CGA | 2007-01-12 |
| 76247 | 1886025590 | K043543 | BLOOD GLUCOSE MONITORING SYSTEM | NBW | 2005-04-08 |
| 76247 | 1236204388 | ||||
| 297459 | 1318559856 | ||||
| 76247 | 1318559856 | ||||
| 76247 | 1523797998 | ||||
| 76247 | 1628388835 | ||||
| 297459 | 1628388835 | ||||
| 76247 | 1806636894 | ||||
| 76247 | 1868495055 | ||||
| 297459 | 1868495055 | ||||
| 76247 | 1886025590 | ||||
| 297459 | 1886025590 | ||||
| 297459 | 2049484297 | ||||
| 76247 | 2049484297 |
Osang, LLC
Osang Healthcare Co. , Ltd.
OSANG Healthcare Co., Ltd.
OSANG Healthcare Co., Ltd.
2020-11-05
2017-12-11
2017-07-21
2021-07-27
2020-10-29
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