Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list OK Biotech Co., Ltd. with 9 510(k) clearances. The most recent is a 510(k) clearance dated Oct 7, 2022: SuperCheck Pro Blood Glucose Monitoring System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 7, 2022 | SuperCheck Pro Blood Glucose Monitoring SystemK213061 · NBW | 510(k) clearances |
| Jan 19, 2017 | UniStrip1 Generic Blood Glucose Test StripsK162430 · NBW | 510(k) clearances |
| Jul 29, 2016 | UniStrip1 Generic Blood Glucose Test StripsK160038 · NBW | 510(k) clearances |
| Jul 20, 2016 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring SystemK152599 · NBW | 510(k) clearances |
| Dec 17, 2015 | PRODIGY iConnect Blood Glucose Monitoring SystemK142785 · NBW | 510(k) clearances |
| Apr 15, 2015 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEMK141914 · NBW | 510(k) clearances |
| Aug 14, 2014 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEMK132633 · NBW | 510(k) clearances |
| Feb 4, 2010 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEMK090609 · NBW | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
