LQN — Latex Agglutination Assay, Rubella Class II
FDA product code LQN covers "Latex Agglutination Assay, Rubella", a Class II medical device regulated under 21 CFR 866.3510. Submissions are reviewed by the Microbiology panel. At least 13 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LQN
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- 510(k)
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K031490 | Immunostics Inc | RUBELLACOL | Jul 16, 2003 |
| K970931 | Sienna Biotech | COPALIS TORC TOTAL ANTIBODY ASSAY | Apr 24, 1997 |
| K961784 | Sienna Biotech | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY… | Oct 31, 1996 |
| K954920 | Murex Diagnostics | MUREX RUB-EX | Aug 21, 1996 |
| K952544 | Seradyn | COLORSLIDER RUBELLA | Jan 17, 1996 |
| K912391 | Orion | RUBALEX, MODIFICATION | May 4, 1992 |
| K901637 | Orion | RESUBMITTED MODIFIED RUBALEX | Apr 26, 1990 |
| K896433 | Biokit Usa | MODIFIED RUBAGEN | Nov 29, 1989 |
| K893755 | Biokit Usa | RUBAGEN | Aug 21, 1989 |
| K861881 | Orion | RUBALEX (REVISED VERSION) | Jun 4, 1986 |
| K852788 | Orion | RUBALEX | Mar 12, 1986 |
| K844436 | Armkel | VIROGEN RUBELLA MICROTITER TEST | May 21, 1985 |
| K844435 | Armkel | VIROGEN RUBELLA SLIDE TEST | May 20, 1985 |