LIC — Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae Class II
FDA product code LIC covers "Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae", a Class II medical device regulated under 21 CFR 866.3390. Submissions are reviewed by the Microbiology panel. At least 9 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LIC
- Device Class
- Class II
- Regulation Number
- 866.3390
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K921075 | Karo Bio Diagnostics | PHADEBACT MONOCLONAL GC TEST, MODIFICATION | May 22, 1992 |
| K911430 | Novo Nordisk Diagnostics | IDEIA(TM) CHLAMYDIA, MODIFICATION | Aug 7, 1991 |
| K880076 | Bainbridge Laboratories | G-MARK | Jul 1, 1988 |
| K874078 | Meridian Diagnostics | MERITEC(TM)-GC | Dec 9, 1987 |
| K871105 | New Horizons Diagnostics | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 |
| K851650 | Pharmacia | PHADEBACT MONOCLONAL GC OMNI TEST | Jul 12, 1985 |
| K850351 | Pharmacia | PHADEBACT MONOCLONAL GC TEST | Mar 13, 1985 |
| K821362 | New Horizons Diagnostics | IMPROVED GONO GEN | Aug 4, 1982 |
| K820007 | New Horizons Diagnostics | NEISSERIA GONORRHOEAE TEST | Jan 29, 1982 |