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
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K960759 | medtex laboratories | GONOPOX TEST KIT | September 18, 1996 |
| K923566 | remel | NIZYME TEST KIT | November 2, 1992 |
| K913456 | kev connecticut diagnostics | VISI-NEISSERIA | October 11, 1991 |
| K880511 | austin biological laboratories | XACT NEISSERIA | August 25, 1988 |
| K881501 | innovative diagnostic systems | MODIFIED IDS RAPID NH SYSTEM | May 18, 1988 |
| K870117 | pro-lab | NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST | March 20, 1987 |
| K853544 | analytical products | QUAD FERM + | September 5, 1985 |
| K852998 | micro-bio-logics | NEISSERIA - KWIK PLUS | July 23, 1985 |
| K852582 | culture kits | GONI-KIT | July 12, 1985 |
| K833307 | pharmacia | PHADEBACK G.C. POSITIVE CONTROLS | December 27, 1983 |
| K833180 | e-y laboratories | GONOCHEK-II | November 14, 1983 |
| K830364 | oxoid u.s.a | NEISSERIA IDENTIFICATION DISCS | March 8, 1983 |
| K812048 | carr-scarborough microbiologicals | IDS RAPIDS NH SYSTEMS | August 18, 1981 |
| K811412 | windsor laboratories | NEISSERIA-KWIK | June 16, 1981 |
| K782013 | abbott laboratories | GONO-CELL | April 23, 1979 |
| K781108 | miles laboratories | MICROCULT-GC CULTURE TEST | August 31, 1978 |