VivaChek Link Plus Blood Glucose Monitoring System
FDA 510(k) K233058 · Vivachek Biotech (Hangzhou) Co., Ltd.
510(k) numberK233058
Submission
- Device name
- VivaChek Link Plus Blood Glucose Monitoring System
- Applicant
- Vivachek Biotech (Hangzhou) Co., Ltd.
Hangzhou, CN - Received
- September 25, 2023
- Decision date
- December 22, 2023
- 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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| K262116 | TRUE METRIX Self Monitoring Blood Glucose SystemNBW · Special | Trividia Health, Inc. | 07/23/2026SE |
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| 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 |
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| K192957 | VivaChek Blood Glucose and B-Ketone Monitoring SystemJIN · Traditional | 06/05/2020SE |
Questions and answers
When was VivaChek Link Plus Blood Glucose Monitoring System cleared by the FDA?
VivaChek Link Plus Blood Glucose Monitoring System (K233058) received a 510(k) decision of Substantially Equivalent on December 22, 2023, 88 days after the submission was received.
What is the product code of K233058?
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.