GL GoodLife Blood Glucose Monitoring System
The GoodLife AC-302 blood glucose meter is used by one person with diabetes for home monitoring. It measures glucose in fresh capillary whole blood from a fingertip using compatible…
The GoodLife AC-302 blood glucose meter is used by one person with diabetes for home monitoring. It measures glucose in fresh capillary whole blood from a fingertip using compatible GoodLife AC blood glucose test strips. It is not intended for diabetes diagnosis or screening, neonatal testing or use across multiple patients.
A blood sample enters the strip’s reaction zone and reacts with chemicals that produce an electrical current. The meter measures that current and calculates the glucose level. The result appears on the LCD screen and is automatically stored for later review.
Listed Item
Only GL GoodLife Blood Glucose Meter. No GCS in package, Economy type
Strip Coding
Inserting a test strip completes an implicit coding process. The meter uses the resulting code parameter in its calculation of the glucose value.
Who Else Makes It
Concentrated in Tianjin (2), Guangdong (2), Jiangsu (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
Record
| Listed by | HMD Biomedical, Inc., Taiwan |
|---|---|
| FDA product code | LFR |
| Device type | Glucose Dehydrogenase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| 510(k) | K113307 |
| Record published | 2016-12-09 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | manufacturing date, serial number |
| Packaging | Pack of 60 |
| Distribution end date | 2016-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AC-11 AC302 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 15 |
| Contour® | Ascensia Diabetes Care US Inc. | 10 |
| Fora | Fora Care Inc. | 9 |
| Contour® Next ONE | Ascensia Diabetes Care US Inc. | 9 |
| True Metrix GO | Trividia Health, Inc. | 8 |
| OneTouch Verio | Lifescan Europe Gmbh | 8 |
| Accu-Chek Aviva Plus | Roche Diagnostics Operations | 7 |
| McKesson | Mckesson Medical-Surgical Inc. | 7 |
| Accu-Chek Guide | Roche Diagnostics Operations | 7 |
| Contour® Next | Ascensia Diabetes Care US Inc. | 6 |
| Accu-Chek Smart View | Roche Diagnostics Operations | 6 |
| FreeStyle Lite | Abbott Diabetes Care Limited | 5 |
Showing 12 of 124. All products under Glucose Dehydrogenase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121433 | 2013-02-14 |
| K113314 | 2012-11-09 |
| K113307 | 2012-07-27 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.