LIC — Antiserum, Coagglutination (Direct) Neisseria Gonorrhoeae Class II
FDA Device Classification
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 | August 7, 1991 |
| K880076 | bainbridge laboratories | G-MARK | July 1, 1988 |
| K874078 | meridian diagnostics | MERITEC(TM)-GC | December 9, 1987 |
| K871105 | new horizons diagnostics | THE GONOGEN II TEST KIT FOR NEISSERIA GONORRHOEAE | May 13, 1987 |
| K851650 | pharmacia | PHADEBACT MONOCLONAL GC OMNI TEST | July 12, 1985 |
| K850351 | pharmacia | PHADEBACT MONOCLONAL GC TEST | March 13, 1985 |
| K821362 | new horizons diagnostics | IMPROVED GONO GEN | August 4, 1982 |
| K820007 | new horizons diagnostics | NEISSERIA GONORRHOEAE TEST | January 29, 1982 |