Gluc-HK
A Glucose test system is a device intended for the quantitative in vitro determination of glucose concentration in serum, lithium plasma and urine
2manufacturers in China registered for this device type
6catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Mindray BIO-Medical Electronics Co., Ltd. | Shenzhen | Guangdong | Specification developer | 61 |
| Roche Diagnostics (Suzhou) Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Randox Laboratories Limited, United Kingdom |
|---|---|
| FDA product code | CFR |
| Device type | Hexokinase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K953210 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 8 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| GL7954 | In distribution | |
| GL2822 | In distribution | |
| GL3881 | In distribution | |
| GL1611 | In distribution | |
| GL8319 | In distribution | |
| GL3816 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Glucoquant GlucoseHK | Roche Diagnostics Gmbh | 3 |
| Glucose HK | Roche Diagnostics Gmbh | 3 |
| AU | Beckman Coulter, Inc. | 3 |
| Teco Diagnostics Glucose (Hexokinase) Reagent Set | Teco Diagnostics | 2 |
| Yumizen C1200 Glucose HK | Horiba ABX SAS | 2 |
| Architect | Abbott Laboratories | 2 |
| Alinity | Abbott Medical | 2 |
| Teco Diagnostics Glucose (Hexokinase) Liquid Reagent | Teco Diagnostics | 2 |
| Atellica CH GluH_3 | Siemens Healthcare Diagnostics Inc | 2 |
| Pointe Scientific, Inc. | Horiba Instruments Incorporated | 2 |
| Architect | Abbott Medical | 2 |
| ABX Pentra Glucose PAP CP | Horiba ABX SAS | 1 |
Showing 12 of 43. All products under Hexokinase, Glucose
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K953210 | 1996-10-25 |
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.