JSX — Kit, Identification, Neisseria Gonorrhoeae Class I
FDA product code JSX covers "Kit, Identification, Neisseria Gonorrhoeae", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- JSX
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- 510(k) Exempt
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K960759 | Medtex Laboratories | GONOPOX TEST KIT | Sep 18, 1996 |
| K923566 | Remel | NIZYME TEST KIT | Nov 2, 1992 |
| K913456 | Kev Connecticut Diagnostics | VISI-NEISSERIA | Oct 11, 1991 |
| K880511 | Austin Biological Laboratories | XACT NEISSERIA | Aug 25, 1988 |
| K881501 | Innovative Diagnostic Systems | MODIFIED IDS RAPID NH SYSTEM | May 18, 1988 |
| K870117 | Pro-Lab | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | Mar 20, 1987 |
| K853544 | Analytical Products | QUAD FERM + | Sep 5, 1985 |
| K852998 | Micro-Bio-Logics | NEISSERIA - KWIK PLUS | Jul 23, 1985 |
| K852582 | Culture Kits | GONI-KIT | Jul 12, 1985 |
| K833307 | Pharmacia | PHADEBACK G.C. POSITIVE CONTROLS | Dec 27, 1983 |
| K833180 | E-Y Laboratories | GONOCHEK-II | Nov 14, 1983 |
| K830364 | Oxoid U.S.A | NEISSERIA IDENTIFICATION DISCS | Mar 8, 1983 |
| K812048 | Carr-Scarborough Microbiologicals | IDS RAPIDS NH SYSTEMS | Aug 18, 1981 |
| K811412 | Windsor Laboratories | NEISSERIA-KWIK | Jun 16, 1981 |
| K782013 | Abbott Laboratories | GONO-CELL | Apr 23, 1979 |
| K781108 | Miles Laboratories | MICROCULT-GC CULTURE TEST | Aug 31, 1978 |