Catalogue number IGM-0021B, listed by Osang Healthcare Co., Ltd., South Korea, under Glucose Oxidase, Glucose. 8 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (3), Zhejiang (2), Jiangsu (1). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Element™Plus Meter | Listed by | Osang Healthcare Co., Ltd., South Korea |
| FDA product code | CGA |
| Device type | Glucose Oxidase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K103021 |
| Record published | 2017-07-21 |
| Record revised | 2018-07-06 (version 3) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Over the counter | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Handling environment temperature 50 to 104 °F; Handling environment humidity 10 to 90 % RH |
| Sizes | Total volume 0.3 Microliter |
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
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.