| Device Type ID | 593 |
| Device Name | Acid, Uric, Uricase (colorimetric) |
| Regulation Description | Uric Acid 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 | 862.1775 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KNK |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 593 |
| Device | Acid, Uric, Uricase (colorimetric) |
| Product Code | KNK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Uric Acid Test System. |
| CFR Regulation Number | 862.1775 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Beckman Coulter Inc. | II | May-12-2017 |
| 2 | Beckman Coulter Inc. | II | Jun-08-2016 |
| 3 | Beckman Coulter Inc. | II | Jan-28-2015 |
| 4 | Horiba Instruments Inc | II | Feb-02-2016 |
| 5 | Ortho-Clinical Diagnostics | II | Oct-17-2016 |
| 6 | Roche Diagnostics Operations, Inc. | II | Jun-27-2015 |
| 7 | Siemens Healthcare Diagnostics, Inc. | II | May-11-2016 |