PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
FDA 510(k) K152599 · Ok Biotech Co., Ltd.
510(k) numberK152599
Submission
- Device name
- PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System
- Applicant
- Ok Biotech Co., Ltd.
Hsinchu City, TW - Received
- September 11, 2015
- Decision date
- July 20, 2016
- 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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|---|---|---|---|
| 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 |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring SystemNBW · Traditional | 12/17/2015SE |
| K141914 | Prodigy Autocode Eject Blood Glucose Monitoring SystemNBW · Traditional | 04/15/2015SE |
| K132633 | Okmeter Direct Blood Glucose Monitoring SystemNBW · Traditional | 08/14/2014SE |
| 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 PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System cleared by the FDA?
PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (K152599) received a 510(k) decision of Substantially Equivalent on July 20, 2016, 313 days after the submission was received.
What is the product code of K152599?
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.