OK Biotech Co., Ltd.
Hsinchu City, TW
OK BIOTECH CO., LTD. appears in FDA device records in Hsinchu City, TW. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for OK Biotech Co., Ltd. between 2007 and 2022. The busiest year on record is 2015, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2007 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K213061 | SuperCheck Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K162430 | UniStrip1 Generic Blood Glucose Test Strips | NBW | Substantially Equivalent | |
| K160038 | UniStrip1 Generic Blood Glucose Test Strips | NBW | Substantially Equivalent | |
| K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K142785 | PRODIGY iConnect Blood Glucose Monitoring System | NBW | Substantially Equivalent | |
| K141914 | PRODIGY AUTOCODE EJECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | |
| K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3005862821 | 3005862821 | OK BIOTECH CO., LTD. | NO. 91, SEC. 2, HSINCHU CITY Hsinchu(County) 30070 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- JQPCalculator/Data Processing Module, For Clinical Use
- LFRGlucose Dehydrogenase, Glucose
- CGAGlucose Oxidase, Glucose
- QUGHearing Aid, Air-Conduction With Wireless Technology, Over The Counter
- CAFNebulizer (Direct Patient Interface)
- CCQNebulizer, Medicinal, Non-Ventilatory (Atomizer)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- FMKSingle Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- FMFSyringe, Piston
- NBWSystem, Test, Blood Glucose, Over The Counter
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain