LQN
13 FDA 510(k) clearances · Product code
182 daysmedian time to decision
300 days90th percentile
13clearances measured
FDA profile
- Official device name
- Latex Agglutination Assay, Rubella
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3510
- Medical specialty
- Microbiology
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| RUBELLACOL (K031490) | Immunostics Inc., | 2003-07-16 |
| COPALIS TORC TOTAL ANTIBODY ASSAY (K970931) | Sienna Biotech, Inc. | 1997-04-24 |
| COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS (K961784) | Sienna Biotech, Inc. | 1996-10-31 |
| MUREX RUB-EX (K954920) | Murex Diagnostics, Inc. | 1996-08-21 |
| COLORSLIDER RUBELLA (K952544) | Seradyn, Inc. | 1996-01-17 |
| RUBALEX, MODIFICATION (K912391) | Orion Corp. | 1992-05-04 |
| RESUBMITTED MODIFIED RUBALEX (K901637) | Orion Corp. | 1990-04-26 |
| MODIFIED RUBAGEN (K896433) | Biokit USA, Inc. | 1989-11-29 |
| RUBAGEN (K893755) | Biokit USA, Inc. | 1989-08-21 |
| RUBALEX (REVISED VERSION) (K861881) | Orion Corp. | 1986-06-04 |
| RUBALEX (K852788) | Orion Corp. | 1986-03-12 |
| VIROGEN RUBELLA MICROTITER TEST (K844436) | Armkel, LLC | 1985-05-21 |
| VIROGEN RUBELLA SLIDE TEST (K844435) | Armkel, LLC | 1985-05-20 |
Track LQN automatically
Every clearance here is in the API, with alerts when new ones post.