| Device Type ID | 2257 |
| Device Name | Control, Hemoglobin |
| Regulation Description | Hematology Quality Control Mixture. |
| Regulation Medical Specialty | Hematology |
| Review Panel | Hematology |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 864.8625 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GGM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2257 |
| Device | Control, Hemoglobin |
| Product Code | GGM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Hematology Quality Control Mixture. |
| CFR Regulation Number | 864.8625 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EUROTROL B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Handling Problem | 1 |
Human-Device Interface Problem | 1 |
| Total Device Problems | 2 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | EUROTROL INC | II | Nov-28-2018 |