Okmeter Direct Blood Glucose Monitoring System
FDA 510(k) K132633 · Ok Biotech Co., Ltd.
510(k) numberK132633
Submission
- Device name
- Okmeter Direct Blood Glucose Monitoring System
- Applicant
- Ok Biotech Co., Ltd.
Hsinchu City, TW - Received
- August 22, 2013
- Decision date
- August 14, 2014
- 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
Other 510(k)s with product code NBW
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|---|---|---|---|
| K260545 | CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose…NBW · Traditional | Ascensia Diabetes Care | 08/27/2026SE |
| 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 |
More from Ascensia Diabetes Care
| 510(k) | Device | Decision |
|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring SystemNBW · Traditional | 10/07/2022SE |
| K162430 | UniStrip1 Generic Blood Glucose Test StripsNBW · Traditional | 01/19/2017SE |
| K160038 | UniStrip1 Generic Blood Glucose Test StripsNBW · Traditional | 07/29/2016SE |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose…NBW · Traditional | 07/20/2016SE |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring SystemNBW · Traditional | 12/17/2015SE |
| K141914 | Prodigy Autocode Eject Blood Glucose Monitoring SystemNBW · Traditional | 04/15/2015SE |
| K090609 | Okmeter Match Blood Glucose Monitoring SystemNBW · Traditional | 02/04/2010SE |
| K063026 | Ok Meter Blood Glucose Monitoring SystemNBW · Traditional | 02/09/2007SE |
Questions and answers
When was Okmeter Direct Blood Glucose Monitoring System cleared by the FDA?
Okmeter Direct Blood Glucose Monitoring System (K132633) received a 510(k) decision of Substantially Equivalent on August 14, 2014, 357 days after the submission was received.
What is the product code of K132633?
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.