Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips
FDA 510(k) K112638 · Nova Biomedical Corporation
510(k) numberK112638
Submission
- Device name
- Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips
- Applicant
- Nova Biomedical Corporation
Walham, MA, US - Received
- September 9, 2011
- Decision date
- March 9, 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
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| 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 |
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Questions and answers
When was Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips cleared by the FDA?
Nova Max One Blood Glucose Monitor, Nova Max One Blood Glucose Test Strips (K112638) received a 510(k) decision of Substantially Equivalent on March 9, 2012, 182 days after the submission was received.
What is the product code of K112638?
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.