Nova One Blood Glucose Monitor
FDA 510(k) K122435 · Nova Biomedical Corporation
510(k) numberK122435
Submission
- Device name
- Nova One Blood Glucose Monitor
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- August 10, 2012
- Decision date
- December 20, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LFR – Glucose Dehydrogenase, Glucose
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1345
- Specialty
- Clinical Chemistry
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|---|---|---|---|
| K152328 | FreeStyle InsuLinx Blood Glucose Monotioring SystemLFR · Special | Abott Laboratories | 09/17/2015SE |
| K142089 | Accu-Chek Aviva Expert SystemLFR · Traditional | Roche Diagnostics Corporation | 12/17/2014SE |
| K133537 | EGV1.1 Self Monitoring Blood Glucose System and EGV1.1 Pro Monitoring Blood Glucose SystemLFR · Special | Eps Bio Technology Corp. | 04/28/2014SE |
| K131727 | Cera-Chek 1070 Blood Glucose Monitoring SystemLFR · Traditional | Ceragem Medisys, Inc. | 02/28/2014SE |
| K131366 | Accu-Chek Aviva Expert Blood Glucose Monitoring SystemLFR · Traditional | Roche Diagnostics Operations, Inc. | 10/11/2013SE |
| K122688 | Nova Max Mini Blood Glucose and B-Ketone MonitorLFR · Traditional | Nova Biomedical Corporation | 04/04/2013SE |
| K121433 | Goodlife CS-200 (Single Patient Use), CS-200 Professional (Multiple Patient Use) Blood…LFR · Traditional | Hmd Biomedical, Inc. | 02/14/2013SE |
| K113314 | Precichek NS-101 Poct Professional Blood Glucose Monitoring SystemLFR · Traditional | Hmd Biomedical, Inc. | 11/09/2012SE |
| K121224 | Genesis Health Technologies Blood Glucose Monitoring SystemLFR · Special | Taidoc Technology Corporation | 09/19/2012SE |
| K113307 | GL Goodlife Series Blood Glucose Monitoring SysmtemLFR · Traditional | Hmd Biomedical, Inc. | 07/27/2012SE |
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| K203549 | Nova Primary Glucose Analyzer SystemCGA · Traditional | 10/18/2022SE |
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Questions and answers
When was Nova One Blood Glucose Monitor cleared by the FDA?
Nova One Blood Glucose Monitor (K122435) received a 510(k) decision of Substantially Equivalent on December 20, 2012, 132 days after the submission was received.
What is the product code of K122435?
The FDA product code is LFR – Glucose Dehydrogenase, Glucose, a Class II (moderate risk) device regulated under 21 CFR 862.1345.