GL GoodLife AC-302 Blood Glucose Monitoring System
The GoodLife AC-302 Blood Glucose Monitoring System measures glucose in fresh capillary whole blood from the fingertips. It is intended for one person with diabetes to test at home and…
The GoodLife AC-302 Blood Glucose Monitoring System measures glucose in fresh capillary whole blood from the fingertips. It is intended for one person with diabetes to test at home and monitor diabetes control, and must not be shared for testing other patients.
A blood sample enters the reaction area of a GoodLife AC test strip. Its reaction generates an electrical current proportional to glucose concentration; the meter calculates the glucose result, displays it on the LCD and stores it for later review.
Listed Item
GL GoodLife AC-302 Blood Glucose Meter (include GCS ),Standard type.
System Checks and Limits
GoodLife glucose control solutions check the performance of the meter and test strips together, while a check strip tests meter operation. The system is not intended for diabetes diagnosis or screening, or for neonatal use.
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.