| Device Type ID | 397 |
| Device Name | Photometric Method, Magnesium |
| Regulation Description | Magnesium 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) |
| CFR Regulation Number | 862.1495 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JGJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 397 |
| Device | Photometric Method, Magnesium |
| Product Code | JGJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Magnesium Test System. |
| CFR Regulation Number | 862.1495 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
High Test Results | 75 |
Low Test Results | 17 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 10 |
Incorrect Or Inadequate Test Results | 10 |
Mechanical Problem | 9 |
Adverse Event Without Identified Device Or Use Problem | 2 |
High Readings | 1 |
Seal | 1 |
Cylinder | 1 |
Tube | 1 |
| Total Device Problems | 127 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories, Inc | II | Mar-01-2019 |
| 2 | Horiba Instruments, Inc Dba Horiba Medical | II | Sep-24-2014 |
| 3 | Randox Laboratories, Limited | II | Dec-08-2016 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Nov-25-2015 |