U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
FDA 510(k) K151100 · Taidoc Technology Corporation
510(k) numberK151100
Submission
- Device name
- U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System
- Applicant
- Taidoc Technology Corporation
New Taipei City, TW - Received
- April 24, 2015
- Decision date
- September 29, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K221349 | XPER Technology PREMIUM Pro Blood Glucose Monitoring SystemPZI · Dual Track | 11/19/2024SE |
| K201037 | FORA ADVANCED GD40 Glucose, ß-Ketone and Cholesterol Monitoring SystemNBW · Traditional | 06/16/2022SE |
| K200946 | Clever Forehead Thermometer / Clever Medical Forehead Thermometer (Model TD-1241)FLL · Traditional | 04/05/2022SE |
| K190579 | TD-4183 Blood Glucose Monitoring SystemNBW · Traditional | 06/04/2019SE |
| K182934 | FORA P100 Blood Pressure Monitoring SystemDXN · Traditional | 02/12/2019SE |
| K180863 | FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal AspiratorBTA · Traditional | 12/19/2018SE |
| K181675 | FORA MD6 Uric Acid Monitoring System, FORA MD6 Pro Uric Acid Monitoring SystemPTC · Traditional | 12/10/2018SE |
| K181588 | POPS! one Blood Glucose Monitoring SystemNBW · Traditional | 11/30/2018SE |
| K172733 | TD-1035 ThermometerFLL · Traditional | 10/22/2018SE |
| K173511 | ActiveCare TD-4121 Blood Glucose Monitoring SystemNBW · Special | 07/12/2018SE |
Questions and answers
When was U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System cleared by the FDA?
U-RIGHT TD-4116 Blood Glucose Monitoring System, U-RIGHT TD-4116 Pro Blood Glucose Monitoring System (K151100) received a 510(k) decision of Substantially Equivalent on September 29, 2015, 158 days after the submission was received.
What is the product code of K151100?
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.