SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System
FDA 510(k) K132929 · Sd Biosensor, Inc.
510(k) numberK132929
Submission
- Device name
- SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System
- Applicant
- Sd Biosensor, Inc.
Mission Viejo, CA, US - Received
- September 17, 2013
- Decision date
- August 5, 2015
- 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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| 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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| K160282 | SD LipidoCare Professional System, SD LipidoCare Home System, SD LipidoCare BT…NBW · Traditional | 10/17/2017SE |
| K153201 | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi…NBW · Special | 06/24/2016SE |
| K151265 | SD GlucoNFC Blood Glucose Monitoring System, SD GlucoNFC Multi Blood Glucose Monitoring…NBW · Traditional | 11/24/2015SE |
| K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetLCP · Traditional | 09/30/2015SE |
| K123517 | Glucomentor Blood Glucose Monitoring System, Glucomentor Multi Blood Glucose Monitoring…NBW · Special | 01/17/2014SE |
Questions and answers
When was SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System cleared by the FDA?
SD Gluconavii Mentor NFC Multi Blood Glucose Monitoring System, and SD Gluconavii Mentor NFC Blood Glucose Monitoring System (K132929) received a 510(k) decision of Substantially Equivalent on August 5, 2015, 687 days after the submission was received.
What is the product code of K132929?
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.