510(k) K970931
- Device
- COPALIS TORC TOTAL ANTIBODY ASSAY
- Applicant
- SIENNA BIOTECH, INC.
- 510(k) number
- K970931
- Product code
- LQN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-04-24
- Date received
- 1997-03-07
- Regulation
- 866.3510
- Classification name
- Latex Agglutination Assay, Rubella
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDITH J SMITH
- Address
- 9115 Guilford Rd., Suite 180 Columbia MD US 21046 21046
FDA Registration Numbers#
- 2029372
- 1641328
Source Documents#
Other 510(k) Records For Product Code LQN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K031490 | RUBELLACOL | Immunostics Inc., | 2003-07-16 |
| K961784 | COPALIS ONE IMMUNOASSAY SYSTEM/TOXOPLASMA GONDII/RUBELLA/CMV TOTAL ANTIBODY ASSAYS | Sienna Biotech, Inc. | 1996-10-31 |
| K954920 | MUREX RUB-EX | Murex Diagnostics, Inc. | 1996-08-21 |
| K952544 | COLORSLIDER RUBELLA | Seradyn, Inc. | 1996-01-17 |
| K912391 | RUBALEX, MODIFICATION | Orion Corp. | 1992-05-04 |
| K901637 | RESUBMITTED MODIFIED RUBALEX | Orion Corp. | 1990-04-26 |
| K896433 | MODIFIED RUBAGEN | Biokit USA, Inc. | 1989-11-29 |
| K893755 | RUBAGEN | Biokit USA, Inc. | 1989-08-21 |
| K861881 | RUBALEX (REVISED VERSION) | Orion Corp. | 1986-06-04 |
| K852788 | RUBALEX | Orion Corp. | 1986-03-12 |
| K844436 | VIROGEN RUBELLA MICROTITER TEST | Armkel, LLC | 1985-05-21 |
| K844435 | VIROGEN RUBELLA SLIDE TEST | Armkel, LLC | 1985-05-20 |
Legacy Summary#
summary
FDA Review#
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