Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042
FDA 510(k) K102345 · Eps Bio Technology Corp.
510(k) numberK102345
Submission
- Device name
- Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042
- Applicant
- Eps Bio Technology Corp.
Hsinchu, TW - Received
- August 19, 2010
- Decision date
- June 21, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- NBW – System, Test, Blood Glucose, Over The Counter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
Other 510(k)s with product code NBW
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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood…NBW · Traditional | ACON Laboratories, Inc. | 10/10/2025SE |
| K243060 | TeleRPM Gen2 Blood Glucose Monitoring SystemNBW · Traditional | Guangdong Transtek Medical Electronics Co., Ltd. | 01/30/2025SE |
| K240637 | RIGHTEST Blood Glucose Monitoring System Max TelNBW · Traditional | Bionime Corporation | 11/04/2024SE |
| K240640 | Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring SystemNBW · Traditional | Sejoy Biomedical Co., Ltd. | 10/08/2024SE |
| K241787 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care U.S., Inc. | 08/27/2024SE |
| K222126 | VivaChek Fad Blood Glucose Monitoring System, VivaChek Fad Smart Blood Glucose…NBW · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 08/16/2024SE |
| K241304 | WaveSense Jazz Blood Glucose Monitoring SystemNBW · Special | Agamatrix | 06/06/2024SE |
| K231679 | CONTOUR® PLUS BLUE Blood Glucose Monitoring SystemNBW · Traditional | Ascensia Diabetes Care | 02/23/2024SE |
More from Ascensia Diabetes Care
| 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 Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042 cleared by the FDA?
Easymax T1 Self Monitoring Blood Glucose System, Model EPS10042 (K102345) received a 510(k) decision of Substantially Equivalent on June 21, 2011, 306 days after the submission was received.
What is the product code of K102345?
The FDA product code is NBW – System, Test, Blood Glucose, Over The Counter, a Class II (moderate risk) device regulated under 21 CFR 862.1345.