AU
3 catalogue numbers from OSR6221, listed by Beckman Coulter, Inc., United States, under Hexokinase, Glucose. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
3catalogue numbers in this listing
2510(k) clearances naming this product code
1recall
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 | Beckman Coulter, Inc., United States |
|---|---|
| FDA product code | CFR |
| Device type | Hexokinase, Glucose |
| Device class | Class 2 |
| Regulation | 21 CFR 862.1345 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K924601 |
| Record published | 2016-09-24 |
| Record revised | 2023-07-06 (version 4) |
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, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| OSR6221 | In distribution | |
| OSR6121 | In distribution | |
| OSR6621 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Gluc-HK | Randox Laboratories Limited | 6 |
| Glucoquant GlucoseHK | Roche Diagnostics Gmbh | 3 |
| Glucose HK | Roche Diagnostics Gmbh | 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 |
|---|---|
| K131189 | 2014-04-17 |
| K060256 | 2006-02-27 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2008-04-03 | Not classified | Nonconforming Material/Component | The field action was initiated after the firm confirmed reports of premature failure of the waste pump tubing in the Access and Access 2 Immunoassay Systems. Premature failure of the waste pump tubing may negatively affect precision. | 694 Worldwide; 656 in US & 38 in Canada total for all produc | 2011-11-29 |
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.