EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose System
FDA 510(k) K133537 · Eps Bio Technology Corp.
510(k) numberK133537
Submission
- Device name
- EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose System
- Applicant
- Eps Bio Technology Corp.
Hsinchu, TW - Received
- November 18, 2013
- Decision date
- April 28, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | Hmd Biomedical, Inc. | 07/27/2012SE |
More from Hmd Biomedical, Inc.
| 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 |
| 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 |
| K112272 | EM44 Self Monitoring Blood Glucose System, EM44 Pro Self Monitoring Blood Glucose SystemLFR · Special | 09/07/2011SE |
Questions and answers
When was EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose System cleared by the FDA?
EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose System (K133537) received a 510(k) decision of Substantially Equivalent on April 28, 2014, 161 days after the submission was received.
What is the product code of K133537?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.