Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
FDA 510(k) K150396 · Apex BioTechnology Corp.
510(k) numberK150396
Submission
- Device name
- Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips
- Applicant
- Apex BioTechnology Corp.
Hsinchu, CN - Received
- February 18, 2015
- Decision date
- October 14, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K212140 | GlucoSure Link Blood Glucose Monitoring SystemNBW · Traditional | 08/25/2022SE |
| K202534 | MTM301 Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 04/06/2022SE |
| K213887 | GAL-1A Plus Blood Glucose Monitoring SystemNBW · Special | 03/29/2022SE |
| K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring SystemNBW · Traditional | 10/15/2021SE |
| K202885 | GlucoSure HT Plus Blood Glucose Monitoring SystemNBW · Special | 09/15/2021SE |
| K182593 | KET-1 Blood Ketone Monitoring SystemJIN · Traditional | 12/18/2018SE |
| K182992 | BGM014 Blood Glucose Monitoring SystemNBW · Special | 11/28/2018SE |
Questions and answers
When was Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips cleared by the FDA?
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips (K150396) received a 510(k) decision of Substantially Equivalent on October 14, 2015, 238 days after the submission was received.
What is the product code of K150396?
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.