Data / Medical devices / Taiwan / Ok Biotech Co., Ltd.
Ok Biotech Co., Ltd.: FDA-registered device maker in HSINCHU CITY Hsinchu(County), Taiwan, 15 510(k) clearances
Ok Biotech Co., Ltd. is registered with the FDA (registration 3005862821) in HSINCHU CITY Hsinchu(County), Taiwan. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated September 15, 2017. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3005862821
- Address
- NO. 91, SEC. 2 Gongdao 5th Rd., HSINCHU CITY Hsinchu(County), Taiwan, 30070
- Owner or operator
- OK BIOTECH CO., LTD. (9090860)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- August 9, 2006
- Registered through
- 2026
- Brand names listed
- Densu Check, Densu Check No Coding, Densu Check Pocket, DocSpray Portable Nebulizer, Easy Plus II, Easy Plus II Multi, Easy Talk, Equate and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Contract manufacturer | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Manufacturer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter | QUG | 2 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Contract manufacturer | accessdata.fda.gov |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | CCQ | 1 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Exporter to the US | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 15, 2017 | K171785 | WowGoHealth Blood Glucose Monitoring System | NBW | Substantially Equivalent | Biotest Medical Corporation | accessdata.fda.gov |
| January 19, 2017 | K162430 | UniStrip1 Generic Blood Glucose Test Strips | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| July 29, 2016 | K160038 | UniStrip1 Generic Blood Glucose Test Strips | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| July 20, 2016 | K152599 | PRODIGY ASTRO Blood Glucose Monitoring System, PRODIGY ASTRO PRO Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| December 17, 2015 | K142785 | PRODIGY iConnect Blood Glucose Monitoring System | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| May 19, 2015 | K141351 | SUPERCHECK PLUS BLOOD GLUCOSE MONITORING SYSTEM, SUPER CHECK PLUS MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| August 14, 2014 | K132633 | OKMETER DIRECT BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| February 21, 2014 | K133509 | EASY PLUS II BLOOD GLUCOSE MONITORING SYSTEM,EASY PLUS II MULTI BLOOD GLUCOSE MONITORING SYSTEM,SMARTEST PERSONA II BLOO | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| May 2, 2013 | K122525 | SMARTEST GLUCOWISE BLOOD GLUCOSE MONITORING SYSTEM, AND SMARTEST GLUCOSWISE MULTI BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| May 12, 2010 | K100560 | EASY TALK BLOOD GLUCOSE MONITORING SYSTEM MODEL: 6277 | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| March 2, 2010 | K093764 | SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| February 4, 2010 | K090609 | OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
| November 16, 2009 | K091815 | SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 | NBW | Substantially Equivalent | Biotest Medical Corp. | accessdata.fda.gov |
| March 5, 2008 | K073118 | PRODIGY VOICE BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Diagnostic Devices, Inc. | accessdata.fda.gov |
| February 9, 2007 | K063026 | OK METER BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Ok Biotech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Glucose Oxidase, Glucose
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Syringe, Piston
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Nebulizer, Medicinal, Non-Ventilatory (Atomizer)
Updated September 15, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.