Eurotrol
11 catalogue numbers from 188.002.002, listed by Eurotrol B.V., Netherlands, under Control, Hemoglobin. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
11catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Eurotrol B.V., Netherlands |
|---|---|
| FDA product code | GGM |
| Device type | Control, Hemoglobin |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | BK030067 |
| Record published | 2016-08-26 |
| Record revised | 2025-01-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Handling environment temperature 15 to 30 °C; Storage environment temperature 2 to 8 °C |
| Distribution end date | 2016-08-27 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 188.002.002 | 2 | In distribution | |
| 139.002.002 | 2 | In distribution | |
| 139.003.002 | 2 | In distribution | |
| 171.002.002 | 2 | In distribution | |
| 188.001.002 | 2 | In distribution | |
| 171.003.002 | 2 | In distribution | |
| 188.003.002 | 2 | In distribution | |
| 023.000.005 | In distribution | ||
| 171.001.002 | 2 | In distribution | |
| 139.001.002 | 2 | In distribution | |
| 250.003.002 | 2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Lyphochek | Bio-Rad Laboratories Inc. | 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 |
|---|---|
| K192842 | 2019-11-15 |
| K182744 | 2019-02-01 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Eurotrol Inc | 510(k) number | 2018-10-18 | Class II | Material/Component Contamination | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values | 2000 | 2020-01-07 |
| Eurotrol Inc | 510(k) number | 2018-10-18 | Class II | Material/Component Contamination | Incorrect measurement results caused by microbial contamination of the product, results in values lower than assigned values | 2122 | 2020-01-07 |
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.