Eurotrol
4 catalogue numbers from 195.004.010, listed by Eurotrol B.V., Netherlands, under Control, Hematocrit. 1 manufacturer in China is registered for this product code.
1manufacturer
4catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Edan Instruments, Inc. | Shenzhen | Guangdong | Contract manufacturer | 56 |
Record
| Listed by | Eurotrol B.V., Netherlands |
|---|---|
| FDA product code | GLK |
| Device type | Control, Hematocrit |
| Device class | Class 2 |
| Regulation | 21 CFR 864.8625 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K121467 |
| Record published | 2016-08-26 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| 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 30 °C |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 195.004.010 | 10 | In distribution | |
| 195.002.010 | 10 | In distribution | |
| 190.000.005 | In distribution | ||
| 195.003.010 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hematocrit Control | Edan Instruments, Inc. | 2 |
| ChemSTAT Hematocrit Evaluator 1 | Instrumentation Laboratory SPA | 1 |
| HemataChek High Control | Separation Technology, Inc. | 1 |
| GEM Hematocrit Evaluator 2 | Instrumentation Laboratory SPA | 1 |
| Hct Check – High Level | Instrumentation Laboratory SPA | 1 |
| HemataChek, Low, Normal, High Control | Separation Technology, Inc. | 1 |
| GEM critCheck | Instrumentation Laboratory SPA | 1 |
| GEM Hematocrit Evaluator 1 | Instrumentation Laboratory SPA | 1 |
| Rapidqc® Hct Level A | Siemens Healthcare Diagnostics Inc | 1 |
| Hct Check – Low Level | Instrumentation Laboratory SPA | 1 |
| HemataChek Low Control | Separation Technology, Inc. | 1 |
| GEM Hematocrit Evaluator 3 | Instrumentation Laboratory SPA | 1 |
Showing 12 of 23. All products under Control, Hematocrit
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K121467 | 2013-05-10 |
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.