| Device Type ID | 6211 |
| Device Name | Colorimetry, Acetaminophen |
| Regulation Description | Acetaminophen 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 | 862.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LDP |
| 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 | 6211 |
| Device | Colorimetry, Acetaminophen |
| Product Code | LDP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Acetaminophen Test System. |
| CFR Regulation Number | 862.3030 [🔎] |
| Device Problems | |
|---|---|
Incorrect, Inadequate Or Imprecise Result Or Readings | 5 |
High Test Results | 5 |
High Readings | 5 |
Low Test Results | 1 |
| Total Device Problems | 16 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | Sep-12-2017 |
| 2 | Roche Diagnostics Corporation | II | Apr-25-2018 |
| 3 | Sekisui Diagnostics P.E.I. Inc. | II | Mar-14-2016 |
| 4 | Siemens Healthcare Diagnostics, Inc. | II | Aug-19-2015 |