Tysonbio Link Health Management System
FDA 510(k) K081726 · Tyson Bioresearch, Inc.
510(k) numberK081726
Submission
- Device name
- Tysonbio Link Health Management System
- Applicant
- Tyson Bioresearch, Inc.
Chun-Nan, Miao-Li County, TW - Received
- June 18, 2008
- Decision date
- August 26, 2008
- 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
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 |
|---|---|---|
| K182046 | Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HS100-B Blood Glucose…NBW · Special | 11/30/2018SE |
| K182047 | Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson Bio HT100-C Blood Glucose…NBW · Special | 11/29/2018SE |
| K170079 | Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HT100-B Blood Glucose…NBW · Traditional | 10/06/2017SE |
| K123087 | Tysonbio AC500, AC800 Blood Glucose Monitoring System, Tysonbio AC500 AC800 Pro Blood…NBW · Special | 06/18/2013SE |
| K112916 | Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring SystemNBW · Traditional | 08/21/2012SE |
| K101543 | Tysonbio Blood Glucose Monitoring System, Models AC100 and AC200NBW · Special | 08/30/2011SE |
| K090629 | Easy Step and Diachex+ Pro Blood Glucose Monitoring SystemsNBW · Special | 06/04/2009SE |
| K072854 | Diachex Basic Blood Glucose Monitoring System, Diachex Superb Blood Glucose Monitoring…NBW · Traditional | 06/30/2008SE |
| K073492 | Diachex+Determine Blood Glucose Monitoring System, Diachex-Infinity Blood Glucose…NBW · Traditional | 04/08/2008SE |
| K072441 | Ez Scan Plus Blood Glucose Monitoring SystemNBW · Traditional | 03/25/2008SE |
Questions and answers
When was Tysonbio Link Health Management System cleared by the FDA?
Tysonbio Link Health Management System (K081726) received a 510(k) decision of Substantially Equivalent on August 26, 2008, 69 days after the submission was received.
What is the product code of K081726?
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.