| Device Type ID | 6061 |
| Device Name | Colorimetry, Salicylate |
| Regulation Description | Salicylate Test System. |
| Regulation Medical Specialty | Toxicology |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.3830 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DKJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 6061 |
| Device | Colorimetry, Salicylate |
| Product Code | DKJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Salicylate Test System. |
| CFR Regulation Number | 862.3830 [🔎] |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 2 |
Insufficient Information | 1 |
| Total Device Problems | 3 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Microgenics Corporation | II | Sep-23-2016 |
| 3 | Siemens Healthcare Diagnostics, Inc. | II | May-04-2018 |