# Ok Biotech Co., Ltd.

- Location (FDA's records): Hsinchu City, TW
- FDA decisions: 9 (2007–2022): 9 510(k) clearances
- Product codes: NBW (9)
- 510(k) review time since 2016: median 259 days, against 239 for FDA's reviews in the same codes and years (3 of 4 faster)
- Predicates its devices cite: 10 (3 its own); citations of its devices by later devices: 3 (3 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Diagnostic Devices, Inc.: 2 (https://510kreport.com/company/diagnostic-devices)
- Prodigy Diabetes Care, LLC: 2 (https://510kreport.com/company/prodigy-diabetes-care)
- Unistrip Technologies, LLC: 1 (https://510kreport.com/company/unistrip-technologies)
- Biotest Medical Corp.: 1 (https://510kreport.com/company/biotest-medical)
- Roche Diagnostics Corp.: 1 (https://510kreport.com/company/roche-diagnostics)

## Its most-cited devices
- K160038: UniStrip1 Generic Blood Glucose Test Strips (2016), cited by 1
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System (2015), cited by 1
- K090609: Okmeter Match Blood Glucose Monitoring System (2010), cited by 1

## Recent decisions
- K213061: SuperCheck Pro Blood Glucose Monitoring System (Oct 7, 2022)
- K162430: UniStrip1 Generic Blood Glucose Test Strips (Jan 19, 2017)
- K160038: UniStrip1 Generic Blood Glucose Test Strips (Jul 29, 2016)
- K152599: PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System (Jul 20, 2016)
- K142785: PRODIGY iConnect Blood Glucose Monitoring System (Dec 17, 2015)
- K141914: Prodigy Autocode Eject Blood Glucose Monitoring System (Apr 15, 2015)
- K132633: Okmeter Direct Blood Glucose Monitoring System (Aug 14, 2014)
- K090609: Okmeter Match Blood Glucose Monitoring System (Feb 4, 2010)

Source page: https://510kreport.com/company/ok-biotech