Panels › Pathology
Pathology devices
83 product codes reviewed by the Pathology panel. 344 510(k) clearances and 257 recalls in the FDA data, 4% of those recalls name a 510(k).
12510(k)s in 12 months
23recalls in 12 months
10recalls that name a 510(k)
Active product codes, Class I
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| OIB | Blood And Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 | 9 |
| PPM | General Purpose Reagent | 1 | 0 | 4 |
| FMH | Container, Specimen, Sterile | 1 | 0 | 3 |
| LEA | Preservative, Cytological | 1 | 0 | 1 |
| MVU | Reagents, Specific, Analyte | 1 | 0 | 1 |
| NNI | Container, Specimen, Non-Sterile | 1 | 0 | 1 |
| OIE | Urine Collection Kit (Excludes Hiv Testing) | 1 | 0 | 1 |
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