Rightest Control Solution GC700
Level 2
20manufacturers in China registered for this device type
1catalogue number
18510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (8), Jiangsu (4), Zhejiang (4). 8 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Sanmina | Kunshan | Jiangsu | Contract manufacturer | 15 |
| Dongguan Honfield Precision Parts Co., Ltd. | Zhangmutou, Dongguan | Guangdong | Contract manufacturer | 8 |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Yasee Biomedical Inc | Qingdao | Shandong | Contract manufacturer | 5 |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
| Dongguan Kaifa Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Andon Health Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 22 |
| Vivachek Biotech (Hangzhou) Co., Ltd. | Hangzhou, Zhuji | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 20. All 20 manufacturers in China registered for System, Test, Blood Glucose, Over The Counter
Record
| Listed by | Bionime Corporation, Taiwan |
|---|---|
| FDA product code | NBW |
| Device type | System, Test, Blood Glucose, Over The Counter |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K190564 |
| Record published | 2025-10-17 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment humidity 10 to 90 % RH; Storage environment temperature 39 to 86 °F |
| Packaging | Paper box, inner carton of 120, outer carton of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GC700 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| True Metrix | Trividia Health, Inc. | 40 |
| Fora | Fora Care Inc. | 31 |
| True Metrix AIR | Trividia Health, Inc. | 21 |
| GE | Bionime Corporation | 21 |
| TRUEtrack | Trividia Health, Inc. | 17 |
| Medline | Medline Industries, Inc. | 15 |
| AgaMatrix | Agamatrix | 15 |
| Tenovi | Tenovi Co | 13 |
| Auvon | Shenzhen Yuwen E-Commerce Co., Ltd. | 11 |
| Accu-Chek Guide | Roche Diagnostics Operations | 10 |
| Curaplex | Bound Tree Medical, LLC | 10 |
| OneTouch Verio | Lifescan Europe Gmbh | 10 |
Showing 12 of 476. All products under System, Test, Blood Glucose, Over The Counter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240637 | 2024-11-04 |
| K231192 | 2024-01-19 |
| K190564 | 2019-06-02 |
| K173638 | 2018-08-17 |
| K173139 | 2018-06-19 |
| K170143 | 2017-07-06 |
| K161790 | 2017-05-02 |
| K140210 | 2014-08-22 |
| K123008 | 2013-01-25 |
| K120423 | 2012-08-03 |
| K110737 | 2012-03-29 |
| K092052 | 2010-06-18 |
| K081451 | 2008-09-18 |
| K081450 | 2008-09-11 |
| K072054 | 2008-02-28 |
| K062567 | 2007-02-16 |
| K053635 | 2006-02-21 |
| K042678 | 2005-01-03 |
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.