FreeStyle Precision Pro
Catalogue number 72011-01, listed by Abbott Diabetes Care Limited, United Kingdom, under Calculator/Data Processing Module, For Clinical Use. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (2), Jiangsu (1). 2 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 |
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Gene Science Co., Ltd. | Shaoxing | Zhejiang | Manufacturer | 31 |
| Foshan Zike Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 8 |
| Shanghai Bestcovered Limited | Shanghai | Shanghai | Manufacturer | 2 |
Record
| Listed by | Abbott Diabetes Care Limited, United Kingdom |
|---|---|
| FDA product code | JQP |
| Device type | Calculator/Data Processing Module, For Clinical Use |
| Device class | Class 1 |
| Regulation | 21 CFR 862.2100 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K132511 |
| Record published | 2020-04-15 |
| Record revised | 2024-05-14 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | lot or batch number, serial number |
| Storage | Storage environment temperature -4 to 122 °F |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72011-01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SoftPathDx | SCC Soft Computer | 69 |
| SoftMolecular | SCC Soft Computer | 67 |
| SoftFlowCytometry | SCC Soft Computer | 67 |
| SoftBiochemistry | SCC Soft Computer | 67 |
| SoftCytogenetics | SCC Soft Computer | 67 |
| SoftMic | SCC Soft Computer | 65 |
| SoftLab | SCC Soft Computer | 64 |
| SoftTrack | SCC Soft Computer | 61 |
| SoftHLA | SCC Soft Computer | 61 |
| SoftGenomics | SCC Soft Computer | 51 |
| SoftGenePortal | SCC Soft Computer | 48 |
| SoftTotalQC | SCC Soft Computer | 28 |
Showing 12 of 140. All products under Calculator/Data Processing Module, For Clinical Use
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.