LIR — Antigen, Enzyme Linked Immunoabsorbent Assay, Neisseria Gonorrhoeae Class II
FDA Device Classification
Classification Details
- Product Code
- LIR
- 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 |
|---|
| K023947 | thermo biostar | GC OIA | April 17, 2003 |
| K882534 | abbott laboratories | ABBOTT TESTPACK(TM) GONORRHEA POSITIVE CONTROL | July 12, 1988 |
| K881064 | hygeia sciences | HYGEIA GC TEST | June 2, 1988 |