| Device Type ID | 5984 |
| Device Name | Mass Spectrometer, Clinical Use |
| Regulation Description | Mass Spectrometer For Clinical Use. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 862.2860 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | DOP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5984 |
| Device | Mass Spectrometer, Clinical Use |
| Product Code | DOP |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Mass Spectrometer For Clinical Use. |
| CFR Regulation Number | 862.2860 [🔎] |
| Device Problems | |
|---|---|
Computer Software Problem | 2 |
Incorrect Or Inadequate Test Results | 1 |
Device Operates Differently Than Expected | 1 |
| Total Device Problems | 4 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ab Sciex | II | Aug-12-2016 |
| 2 | Ab Sciex | II | May-15-2016 |
| 3 | Ab Sciex | II | Apr-29-2016 |
| 4 | Ab Sciex | II | Sep-08-2014 |
| 5 | PerkinElmer Health Sciences Canada, Inc. | II | Nov-28-2018 |
| 6 | Thermo Finnigan LLC | II | Sep-09-2016 |