FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
FDA 510(k) clearance K161738 · decided 2016-11-10
Clearance details
- K-number
- K161738
- Device name
- FORA ADVANCED GD40 and FORA ADVANCED GD40 pro Blood Glucose and ß-Ketone Monitoring Systems
- Applicant
- Taidoc Technology Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-06-23
- Decision date
- 2016-11-10
- Days to decision
- 140 days
- Clearance type
- Traditional
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- New Taipei City, TW
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
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| RIGHTEST Blood Glucose Monitoring System Max Tel (K240637) | Bionime Corporation | 2024-11-04 |
| Sejoy Blood Glucose Monitoring System; Sejoy Advance Link Blood Glucose Monitoring System (K240640) | Sejoy Biomedical Co., Ltd. | 2024-10-08 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System; CONTOUR® NEXT GEN Blood Glucose Monitoring System (K241787) | Ascensia Diabetes Care U.S., Inc. | 2024-08-27 |
| VivaChek™ Fad Blood Glucose Monitoring System, VivaChek™ Fad Smart Blood Glucose Monitoring System, VivaChek™ Fad Sync Blood Glucose Monitoring System (K222126) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2024-08-16 |
| WaveSense Jazz Blood Glucose Monitoring System (K241304) | Agamatrix | 2024-06-06 |
| CONTOUR® PLUS BLUE Blood Glucose Monitoring System (K231679) | Ascensia Diabetes Care | 2024-02-23 |
| RIGHTEST Blood Glucose Monitoring System Max Tel (K231192) | Bionime Corporation | 2024-01-19 |
| VivaChek Link Plus Blood Glucose Monitoring System (K233058) | Vivachek Biotech (Hangzhou) Co., Ltd. | 2023-12-22 |
| TRUENESS™ AIR Blood Glucose Monitoring System; TRUENESS™ Blood Glucose Monitoring System (K231476) | Sinocare, Inc. | 2023-12-01 |
Recalls involving this device
No recalls on record reference this clearance.