JSX
16 FDA 510(k) clearances · Product code
62 daysmedian time to decision
198 days90th percentile
16clearances measured
FDA profile
- Official device name
- Kit, Identification, Neisseria Gonorrhoeae
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Medical specialty
- Microbiology
- Adverse events (MAUDE)
- 1995: 1 · 1998: 1 · 2001: 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 |
|---|---|---|
| GONOPOX TEST KIT (K960759) | Medtex Laboratories, Inc. | 1996-09-18 |
| NIZYME TEST KIT (K923566) | Remel Co. | 1992-11-02 |
| VISI-NEISSERIA (K913456) | Kev Connecticut Diagnostics, Inc. | 1991-10-11 |
| XACT NEISSERIA (K880511) | Austin Biological Laboratories | 1988-08-25 |
| MODIFIED IDS RAPID NH SYSTEM (K881501) | Innovative Diagnostic Systems, Inc. | 1988-05-18 |
| NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST (K870117) | Pro-Lab, Inc. | 1987-03-20 |
| QUAD FERM + (K853544) | Analytical Products, Inc. | 1985-09-05 |
| NEISSERIA - KWIK PLUS (K852998) | Micro-Bio-Logics | 1985-07-23 |
| GONI-KIT (K852582) | Culture Kits, Inc. | 1985-07-12 |
| PHADEBACK G.C. POSITIVE CONTROLS (K833307) | Pharmacia, Inc. | 1983-12-27 |
| GONOCHEK-II (K833180) | E-Y Laboratories, Inc. | 1983-11-14 |
| NEISSERIA IDENTIFICATION DISCS (K830364) | Oxoid U.S.A., Inc. | 1983-03-08 |
| IDS RAPIDS NH SYSTEMS (K812048) | Carr-Scarborough Microbiologicals, Inc. | 1981-08-18 |
| NEISSERIA-KWIK (K811412) | Windsor Laboratories, Inc. | 1981-06-16 |
| GONO-CELL (K782013) | Abbott Laboratories | 1979-04-23 |
| MICROCULT-GC CULTURE TEST (K781108) | Miles Laboratories, Inc. | 1978-08-31 |
Track JSX automatically
Every clearance here is in the API, with alerts when new ones post.