Bioland Blood Glucose Monitoring System
FDA 510(k) K191657 · Bioland Technology, Ltd.
510(k) numberK191657
Submission
- Device name
- Bioland Blood Glucose Monitoring System
- Applicant
- Bioland Technology, Ltd.
Shenzhen, CN - Received
- June 21, 2019
- Decision date
- March 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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
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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
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|---|---|---|
| K202739 | Bioland G-425-2V Blood Glucose Monitoring System, Bioland G-425-2 Blood Glucose…NBW · Special | 08/12/2022SE |
| K213011 | Infrared Thermometer (model: E201)FLL · Traditional | 04/05/2022SE |
| K201879 | Digital Thermometer Model T103, T104FLL · Traditional | 03/31/2021SE |
| K202934 | Blood Pressure MonitorDXN · Traditional | 01/26/2021SE |
| K201161 | Infrared Thermometer Model E127FLL · Traditional | 10/02/2020SE |
| K201467 | Blood Pressure Monitor-Model 2005, 2006-2, 2006-2BDXN · Traditional | 09/21/2020SE |
| K083681 | Bioland Blood Pressure MonitorDXN · Traditional | 01/16/2009SE |
Questions and answers
When was Bioland Blood Glucose Monitoring System cleared by the FDA?
Bioland Blood Glucose Monitoring System (K191657) received a 510(k) decision of Substantially Equivalent on March 20, 2020, 273 days after the submission was received.
What is the product code of K191657?
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.