| Device Type ID | 447 |
| Device Name | Photometric Method, Iron (non-heme) |
| Regulation Description | Iron (non-heme) Test System. |
| 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 | 862.1410 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JIY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 447 |
| Device | Photometric Method, Iron (non-heme) |
| Product Code | JIY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Iron (non-heme) Test System. |
| CFR Regulation Number | 862.1410 [🔎] |
| Device Problems | |
|---|---|
Low Test Results | 2 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Siemens Healthcare Diagnostics, Inc. | III | Nov-11-2016 |
| 2 | Sterling Diagnostics, Inc. | III | Dec-29-2016 |