Data / Medical devices / Taiwan / Apex Biotechnology Corp.
Apex Biotechnology Corp.: FDA-registered device maker in HSINCHU Hsinchu(County), Taiwan, 11 510(k) clearances
Apex Biotechnology Corp. is registered with the FDA (registration 9616936) in HSINCHU Hsinchu(County), Taiwan. It lists 8 device types. The FDA files 11 510(k) clearances under its listings, the newest dated April 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9616936
- FEI number
- 3002671736
- Address
- No. 7, Li-Hsin Road V, Hsinchu Science Park, HSINCHU Hsinchu(County), Taiwan, 30078
- Owner or operator
- APEX BIOTECHNOLOGY CORP. (9034629)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- June 12, 2007
- Registered through
- 2026
- Brand names listed
- AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM, Assure Platinum Test Strips, Assure Titanium Test Strips, AutoSure Voice BGMS, CVS Embrace Talking, CVS Health Embrace Talking, Embrace EVO, Embrace No Code BGMS and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Acid, Lactic, Enzymatic Method | KHP | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Prescription Use Blood Glucose Meter For Near-Patient Testing | PZI | 2 | Contract manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Contract manufacturer, Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Uric Acid Test System For At Home Prescription Use | PTC | 1 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 4, 2025 | K242209 | UASure II Blood Uric Acid Monitoring System | PTC | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| November 4, 2022 | K220421 | BGM039 Blood Glucose Monitoring System, BGM039 Link Blood Glucose Monitoring System | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| August 25, 2022 | K212140 | GlucoSure Link Blood Glucose Monitoring System | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| March 29, 2022 | K213887 | GAL-1A Plus Blood Glucose Monitoring System | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| October 15, 2021 | K201880 | MultiSure GK Link Blood Glucose and Ketone Monitoring System | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| December 23, 2016 | K161299 | BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| April 6, 2012 | K120448 | MEG-2B BLOOD GLUCOSE MONITORING SYSTEM, PRO BLOOD GLUCOSE MONITORING SYSTEM, BLOOD GLUCOSE TEST STRIPS, GLUCOSE CONTROL | CGA | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| January 26, 2012 | K113208 | GAL-1A BLOOD GLUCOSE MONITORING SYSTEM | CGA | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| January 17, 2012 | K113098 | AUTOSURE VOICE II PLUS, AUTOSURE PLUS BLOOD GLUCOSE TEST STRIPS,CONTREX PLUS III | NBW | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| August 13, 2010 | K102037 | AUTOSURE VOICE II BLOOD GLUCOSE MONITORING SYSTEM AND TEST STRIPS | CGA | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
| April 9, 2009 | K090043 | AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 | CGA | Substantially Equivalent | Apex BioTechnology Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Nitroprusside, Ketones (Urinary, Non-Quant.)
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Prescription Use Blood Glucose Meter For Near-Patient Testing
- All makers of Glucose Oxidase, Glucose
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
- All makers of Uric Acid Test System For At Home Prescription Use
Updated April 4, 2025. 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.