ReliOn Premier BLU Blood Glucose Monitoring System
I-Sens, Inc.
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014697030 | 3014697030 | i-SENS, Inc. | 1 | N | 2020-04-25 | 4th floor, 39-36, Nonhyeon-ro 46beon-gil, Namdong-gu Incheon Gwangyeogsiv KR 21655 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00885325000856 | KetoSens - KetoSens B-Ketone Monitoring System with Lancets | 1-800-429-5001 | cs1@i-sens.com |
| 00885325001495 | KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | 1-800-429-5001 | cs1@i-sens.com |
| 10885325000853 | KetoSens - KetoSens B-Ketone Monitoring System with Lancets | 1-800-429-5001 | cs1@i-sens.com |
| 10885325001492 | KetoSens - KetoSens BT B-Ketone Monitoring System with Test Strips (individually foiled packs x 10) | 1-800-429-5001 | cs1@i-sens.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 228005 | 1746346829 | K183255 | Coag-Sense Prothrombin Time (PT) / INR Monitoring Device | GJS | 2019-02-21 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GJS | 1 | 2019-02-21 |
I-Sens, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, INC.
I-Sens, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
I-SENS, Inc.
2020-11-10
2020-11-10
2020-11-10
2020-11-10
2023-07-11
2023-07-11
2023-07-11
2023-07-11
2023-07-11
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2023-01-26
2016-09-23
2022-07-18
2022-07-18
2022-07-18
2022-07-18
2021-02-17
2021-02-17
2021-02-17
2021-02-17
2021-02-17
2021-02-17
2021-02-17
2021-02-17
2020-11-11
2020-11-11
2020-11-10
2020-11-10
2020-11-10
2020-11-10
2020-11-10