Panels › Microbiology › Product code LQN · Class 2
Latex Agglutination Assay, Rubella
Regulation 866.3510
0510(k)s in 12 months (13 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LQN
| Company | 510(k)s | Recalls |
|---|---|---|
| Orion Corp. | 4 | 0 |
| Armkel, LLC | 2 | 0 |
| Biokit USA, Inc. | 2 | 0 |
| Sienna Biotech, Inc. | 2 | 0 |
| Immunostics Inc., | 1 | 0 |
| Murex Diagnostics, Inc. | 1 | 0 |
| Seradyn, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 16, 2003 | K031490 | RUBELLACOL Immunostics Inc., | LQN |
| Apr 24, 1997 | K970931 | COPALIS TORC TOTAL ANTIBODY ASSAY Sienna Biotech, Inc. | LQN |
| Oct 31, 1996 | K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS Sienna Biotech, Inc. | LQN |
| Aug 21, 1996 | K954920 | MUREX RUB-EX Murex Diagnostics, Inc. | LQN |
| Jan 17, 1996 | K952544 | COLORSLIDER RUBELLA Seradyn, Inc. | LQN |
| May 4, 1992 | K912391 | RUBALEX, MODIFICATION Orion Corp., FI | LQN |
| Apr 26, 1990 | K901637 | RESUBMITTED MODIFIED RUBALEX Orion Corp., FI | LQN |
| Nov 29, 1989 | K896433 | MODIFIED RUBAGEN Biokit USA, Inc., ES | LQN |
| Aug 21, 1989 | K893755 | RUBAGEN Biokit USA, Inc., ES | LQN |
| Jun 4, 1986 | K861881 | RUBALEX (REVISED VERSION) Orion Corp., FI | LQN |
| Mar 12, 1986 | K852788 | RUBALEX Orion Corp., FI | LQN |
| May 21, 1985 | K844436 | VIROGEN RUBELLA MICROTITER TEST Armkel, LLC | LQN |
| May 20, 1985 | K844435 | VIROGEN RUBELLA SLIDE TEST Armkel, LLC | LQN |
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