Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System
FDA 510(k) K131013 · Nova Biomedical Corporation
510(k) numberK131013
Submission
- Device name
- Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- April 11, 2013
- Decision date
- October 17, 2013
- 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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| 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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Questions and answers
When was Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System cleared by the FDA?
Focus Blood Glucose Monitoring System, Focus Pro Blood Glucose Monitoring System (K131013) received a 510(k) decision of Substantially Equivalent on October 17, 2013, 189 days after the submission was received.
What is the product code of K131013?
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.