Eg V1 (BL) Self Monitoring Glucose Test System Model: EPS10017
FDA 510(k) K101037 · Eps Bio Technology Corp.
510(k) numberK101037
Submission
- Device name
- Eg V1 (BL) Self Monitoring Glucose Test System Model: EPS10017
- Applicant
- Eps Bio Technology Corp.
Hsinchu, TW - Received
- April 14, 2010
- Decision date
- May 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LFR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR · Special | Abott Laboratories | 09/17/2015SE |
| K142089 | Accu-Chek Aviva Expert SystemLFR · Traditional | Roche Diagnostics Corporation | 12/17/2014SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | Eps Bio Technology Corp. | 04/28/2014SE |
| K131727 | Cera-Chek 1070 Blood Glucose Monitoring SystemLFR · Traditional | Ceragem Medisys, Inc. | 02/28/2014SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | Roche Diagnostics Operations, Inc. | 10/11/2013SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | Nova Biomedical Corporation | 04/04/2013SE |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| K122435 | Nova One Blood Glucose MonitorLFR · Traditional | Nova Biomedical Corporation | 12/20/2012SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | Hmd Biomedical, Inc. | 11/09/2012SE |
| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
More from Taidoc Technology Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K201258 | EASYMAX Tag Self-Monitoring Blood Glucose SystemNBW · Special | 09/01/2021SE |
| K190189 | MDT2 BLE Self-Monitoring Blood Glucose SystemNBW · Special | 11/01/2019SE |
| K182057 | EasyMax BT Self-Monitoring Blood Glucose SystemNBW · Special | 08/24/2018SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | 04/28/2014SE |
| K133389 | EM40 Self-Monitoring Blood Glucose SystemNBW · Special | 04/15/2014SE |
| K133647 | EMV3.1 Pro Blood Glucose System and EMV3.1 Self Monitoring Blood Glucose SystemNBW · Special | 02/27/2014SE |
| K121207 | Easymax Mu Self Monitoring Blood Glucose System, Easymax Mu Pro Self Monitoring Blood…LFR · Special | 05/18/2012SE |
| K113243 | EM50 Self Monitoring Blood Glucose SystemLFR · Traditional | 03/28/2012SE |
| K112901 | Eme Self Monitoring Blood Glucose System, Eme Pro Self Monitoring Blood Glucose SystemLFR · Special | 12/23/2011SE |
| K111728 | EMV3 Self Monitoring Blood Glucose System, EMV3 Pro Self Monitoring Blood Glucose SystemCGA · Special | 09/16/2011SE |
Questions and answers
When was Eg V1 (BL) Self Monitoring Glucose Test System Model: EPS10017 cleared by the FDA?
Eg V1 (BL) Self Monitoring Glucose Test System Model: EPS10017 (K101037) received a 510(k) decision of Substantially Equivalent on May 23, 2011, 404 days after the submission was received.
What is the product code of K101037?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.