RUBALEX (REVISED VERSION)
FDA 510(k) clearance K861881 · decided 1986-06-04
Clearance details
- K-number
- K861881
- Device name
- RUBALEX (REVISED VERSION)
- Applicant
- Orion Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-05-08
- Decision date
- 1986-06-04
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- LQN
- Device class
- 2
- Regulation number
- 866.3510
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- 20101 Turku, FI
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| 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 (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 |
Recalls involving this device
No recalls on record reference this clearance.