| Device Type ID | 466 |
| Device Name | Controls For Blood-gases, (assayed And Unassayed) |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.1660 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JJS |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 466 |
| Device | Controls For Blood-gases, (assayed And Unassayed) |
| Product Code | JJS |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Quality Control Material (assayed And Unassayed). |
| CFR Regulation Number | 862.1660 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
EUROTROL B.V. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOMETER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RADIOMETER MEDICAL APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Human Factors Issue | 1 |
| Total Device Problems | 1 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Radiometer America Inc | II | Sep-29-2017 |