Greensboro, NC, US · 1 510(k) clearances · 2 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | Clinical Toxicology | 1 | 2022-01-27 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-02-10 | Class II | Terminated | Z-1701-2020 | SPICE (JWH-018) CC443 | — | Corrections are being made to the device labeling regarding its intended use, to include a statement clarifying it is for research purposes only. |
| 2020-01-20 | Class II | Terminated | Z-1743-2020 | Fentanyl Reagent Kit, Product N. CC444, Contains: FENT R1 Reagent and FENT R2 Reagent | — | Labeled for diagnostic use and sold to clinical labs without a 510(k). Firm corrected labeling to remove clinical diagnostic language and notified customers th… |