JXO
6 FDA 510(k) clearances · Product code
163 daysmedian time to decision
414 days90th percentile
6clearances measured
FDA profile
- Official device name
- Enzyme Immunoassay, Cocaine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Medical specialty
- Clinical Toxicology
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1998: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| Psychemedics Homogeneous Enzyme Immunoassay for Cocaine in Hair (K201228) | Psychemedics Corporation | 2021-06-25 |
| PSYCHEMEDICS COCAINE EIA (K111925) | Psychemedics Corp. | 2012-05-01 |
| AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY (K923314) | Serex, Inc. | 1992-08-24 |
| STC DIAGNOSTICS AUTO0LYTE COCAINE METABOLITE EIA (K921140) | Solarcare Technologies Corp,Inc. | 1992-08-20 |
| STC DIAGNOSTICS BENZOYLECGONINE EIA (K915785) | Solarcare Technologies Corp,Inc. | 1992-03-11 |
| IL TEST(TM) COCAINE (K913737) | Instrumentation Laboratory CO | 1991-12-03 |
Track JXO automatically
Every clearance here is in the API, with alerts when new ones post.