LQN — Latex Agglutination Assay, Rubella Class II
FDA Device Classification
Classification Details
- Product Code
- LQN
- Device Class
- Class II
- Regulation Number
- 866.3510
- Submission Type
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K031490 | immunostics inc | RUBELLACOL | July 16, 2003 |
| K970931 | sienna biotech | COPALIS TORC TOTAL ANTIBODY ASSAY | April 24, 1997 |
| K961784 | sienna biotech | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSA | October 31, 1996 |
| K954920 | murex diagnostics | MUREX RUB-EX | August 21, 1996 |
| K952544 | seradyn | COLORSLIDER RUBELLA | January 17, 1996 |
| K912391 | orion | RUBALEX, MODIFICATION | May 4, 1992 |
| K901637 | orion | RESUBMITTED MODIFIED RUBALEX | April 26, 1990 |
| K896433 | biokit usa | MODIFIED RUBAGEN | November 29, 1989 |
| K893755 | biokit usa | RUBAGEN | August 21, 1989 |
| K861881 | orion | RUBALEX (REVISED VERSION) | June 4, 1986 |
| K852788 | orion | RUBALEX | March 12, 1986 |
| K844436 | armkel | VIROGEN RUBELLA MICROTITER TEST | May 21, 1985 |
| K844435 | armkel | VIROGEN RUBELLA SLIDE TEST | May 20, 1985 |