Data / Medical devices / United States / Bionime Usa Corporation
Bionime Usa Corporation: FDA-registered device maker in Ontario, CA, United States, 19 510(k) clearances
Bionime Usa Corporation is registered with the FDA (registration 3006755541) in Ontario, CA, United States. It lists 7 device types. The FDA files 19 510(k) clearances under its listings, the newest dated November 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006755541
- Address
- 1450 E. Spruce Street, Bldg. #B, Ontario, CA, United States, 91761
- Owner or operator
- BIONIME USA CORPORATION (10024947)
- Roles
- Complaint file establishment
- First device listed
- November 16, 2011
- Registered through
- 2026
- Brand names listed
- Bionime Rightest Blood Glucose Monitoring System, Bionime Rightest Diabetes Management System, Diathrive+ Blood Glucose Monitoring System, Diathrive+ Bluetooth Blood Glucose Monitoring System, GE 300 Talking Blood Glucose Monitoring System, GE 333 Control Solution, GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calculator/Data Processing Module, For Clinical Use | JQP | 1 | Complaint file establishment | accessdata.fda.gov |
| Glucose Dehydrogenase, Glucose | LFR | 2 | Complaint file establishment | accessdata.fda.gov |
| Glucose Oxidase, Glucose | CGA | 2 | Complaint file establishment | accessdata.fda.gov |
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Complaint file establishment | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Complaint file establishment | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 2 | Complaint file establishment | 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 |
|---|---|---|---|---|---|---|
| November 4, 2024 | K240637 | RIGHTEST Blood Glucose Monitoring System Max Tel | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| September 26, 2022 | K221062 | RIGHTEST Lancing Device GD500, GE Lancing Device, iGlucose Lancing Device | QRL | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| August 31, 2022 | K221507 | Disposable Blood Lancet | QRK | Substantially Equivalent | SteriLance Medical (Suzhou), Inc. | accessdata.fda.gov |
| July 6, 2022 | K220475 | Lancet (I, II, III, V, VI); Lancing device (HH-X-T, HH-XIII-T, HH-XV-T, HH-XVI-T, HH-XVII-T, HH-XVIII-T, HH-XIX, HH-XXI-T, HH-XXII-T, HH-XXIII-T, HH-XXIV-T) | QRL | Substantially Equivalent | Tianjin Huahong Technology Co., Ltd. | accessdata.fda.gov |
| June 2, 2019 | K190564 | Rightest Blood Glucose Monitoring System GM700S, Rightest Blood Glucose Monitoring System GM700SB | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| August 17, 2018 | K173638 | Rightest Blood Glucose Monitoring System Max, Rightest Blood Glucose Monitoring System Max Plus, GE Blood Glucose Monitoring System Max, GE Blood Glucose Monitoring System Max Plus | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 19, 2018 | K173139 | Rightest Blood Glucose Monitoring System Wiz, Rightest Blood Glucose Monitoring System Wiz Plus | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| July 6, 2017 | K170143 | GE Blood Glucose Monitoring System 180, GE Blood Glucose Monitoring System 182, Rightest Blood Glucose Monitoring System GM280, Rightest Blood Glucose Monitoring System GM280B, | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 9, 2015 | K141292 | Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Coporation | accessdata.fda.gov |
| June 3, 2015 | K143387 | GE333 Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bionime Coporation | accessdata.fda.gov |
| August 22, 2014 | K140210 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM ( GM720, RIGHTEST PROFESSIONAL BGMS GM720 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| April 17, 2014 | K133522 | RIGHTEST DIABETES MANAGEMENT SOFTWARE AND ADAPTER (EXISTING CLEARED K113007),RIGHTEST NEW ADAPTERS-3,GE DIABETES MANAGEM | NBW | Substantially Equivalent | Bionime Coporation | accessdata.fda.gov |
| October 24, 2013 | K133003 | RIGHTEST CONTROL SOLUTION | JJX | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| January 25, 2013 | K123008 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| March 29, 2012 | K110737 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| June 18, 2010 | K092052 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM550 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| September 18, 2008 | K081451 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| February 16, 2007 | K062567 | RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
| February 21, 2006 | K053635 | MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM | NBW | Substantially Equivalent | Bionime Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of System, Test, Blood Glucose, Over The Counter
- All makers of Glucose Oxidase, Glucose
- All makers of Glucose Dehydrogenase, Glucose
- All makers of Calculator/Data Processing Module, For Clinical Use
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated November 4, 2024. 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.