Lyphochek
Lyphochek Diabetes Control Bilevel MiniPak (A human whole blood assayed diabetes control.)
2manufacturers in China registered for this device type
3catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (1), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acon Biotech (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Urit Medical Electronic Co., Ltd. | Guilin | Guangxi | Contract manufacturer | 28 |
Record
| Listed by | Bio-Rad Laboratories Inc., United States |
|---|---|
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K070546 |
| Record published | 2016-09-12 |
| Record revised | 2023-01-31 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 740X | In distribution | |
| 12000070 | In distribution | |
| 740 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Eurotrol | Eurotrol B.V. | 11 |
| CueSee® Co-OX | Eurotrol B.V. | 11 |
| Research and Diagnostic Systems | Research AND Diagnostic Systems, Inc. | 10 |
| Liquichek | Bio-Rad Laboratories Inc. | 8 |
| InteliQ | Bio-Rad Laboratories Inc. | 4 |
| Hemoglobin Test Strip | Urit Medical Electronic Co., Ltd. | 3 |
| HemoTrol Duo | Eurotrol B.V. | 3 |
| McKesson | Mckesson Medical-Surgical Inc. | 3 |
| HemoTrol WB | Eurotrol B.V. | 3 |
| Hemoglobin Control Solution | Urit Medical Electronic Co., Ltd. | 3 |
| Hemoglobin Meter | Urit Medical Electronic Co., Ltd. | 2 |
| Henry Schein | Henry Schein, Inc. | 1 |
Showing 12 of 25. All products under Control, Hemoglobin
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K070546 | 2007-04-02 |
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.