Longford, IE · 8 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | Class II | Clinical Chemistry | 1 | 2023-07-21 |
| CIG | Diazo Colorimetry, Bilirubin | Class II | Clinical Chemistry | 1 | 2022-12-29 |
| CHH | — | — | — | 1 | 2022-06-30 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | Class II | Clinical Chemistry | 1 | 2022-05-31 |
| JFJ | Catalytic Methods, Amylase | Class II | Clinical Chemistry | 1 | 2022-05-26 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | Class II | Clinical Chemistry | 1 | 2022-03-22 |
| CJW | Bromcresol Purple Dye-Binding, Albumin | Class II | Clinical Chemistry | 1 | 2022-03-18 |
| CIX | Bromcresol Green Dye-Binding, Albumin | Class II | Clinical Chemistry | 1 | 2021-11-23 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2023-07-21 | K223317 | Alkaline Phosphatase2 | CJE | Class II | Clinical Chemistry |
| 2022-12-29 | K223324 | Total Bilirubin2 | CIG | Class II | Clinical Chemistry |
| 2022-06-30 | K203597 | Cholesterol2 | CHH | — | — |
| 2022-05-31 | K203771 | Urea Nitrogen2 | CDQ | Class II | Clinical Chemistry |
| 2022-05-26 | K210633 | Amylase2 | JFJ | Class II | Clinical Chemistry |
| 2022-03-22 | K210452 | Creatinine2 | CGX | Class II | Clinical Chemistry |
| 2022-03-18 | K203530 | Albumin BCP2 | CJW | Class II | Clinical Chemistry |
| 2021-11-23 | K203248 | Albumin BCG2 | CIX | Class II | Clinical Chemistry |