Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring System
FDA 510(k) K112916 · Tyson Bioresearch, Inc.
510(k) numberK112916
Submission
- Device name
- Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring System
- Applicant
- Tyson Bioresearch, Inc.
Chu-Nan, Miao-Li County, TW - Received
- October 3, 2011
- Decision date
- August 21, 2012
- 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
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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 |
|---|---|---|
| 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 |
| 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 |
| K081726 | Tysonbio Link Health Management SystemNBW · Traditional | 08/26/2008SE |
| 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 MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring System cleared by the FDA?
Tysonbio MD100 Blood Glucse Monitoring ,Tysonbio MD100 Pro Blood Glucise Monitoring System (K112916) received a 510(k) decision of Substantially Equivalent on August 21, 2012, 323 days after the submission was received.
What is the product code of K112916?
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.