Varelisa Ana Profile
FDA 510(k) K951205 · Elias U.S.A., Inc.
510(k) numberK951205
Submission
- Device name
- Varelisa Ana Profile
- Applicant
- Elias U.S.A., Inc.
Osceola, WI, US - Received
- March 17, 1995
- Decision date
- April 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LJM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K182353 | EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayLJM · Traditional | Phadia AB | 11/27/2018SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | Immco Diagnostics, Inc. | 03/11/2016SE |
| K140493 | Elia SCL-70S ImmunoassayLJM · Traditional | Phadia GmbH | 10/30/2014SE |
| K123880 | Quanta Flash CentromereLJM · Traditional | Inova Diagnostics, Inc. | 02/07/2014SE |
| K131330 | Gold Standard Diagnostics Anti-Nuclear Antibody (Ana) Screen Elisa Test KitLJM · Traditional | Gold Standard Diagnostics | 01/28/2014SE |
| K131185 | Ana Screen Elisa (Igg)LJM · Traditional | Euroimmun US | 07/15/2013SE |
| K083188 | Varelisa Recombi Ana Screen, Model 12 596LJM · Traditional | Phadia US, Inc. | 03/13/2009SE |
| K050967 | Varelisa Recombi CTD Screen, Model 13096LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 06/28/2005SE |
| K050625 | Varelisa Recombi Ana Profile, Model 18496LJM · Traditional | Sweden Diagnostics (Germany) GmbH | 04/26/2005SE |
| K041102 | Immulisa Antinuclear Antibody Screen ElisaLJM · Traditional | Immco Diagnostics, Inc. | 10/26/2004SE |
More from Immco Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K964385 | Elias ANA-HEP-2LJM · Traditional | 03/06/1997SE |
| K963291 | Varelisa Ana (4) ProfileLJM · Traditional | 09/30/1996SE |
| K953873 | Varelisa Helicobacter Pylori AntibodiesLYR · Traditional | 08/30/1996SE |
| K953587 | Varelisa Mpo-AncaMOB · Traditional | 01/26/1996SE |
| K953586 | Varelisa PR3-ANCAMOB · Traditional | 01/26/1996SE |
| K951187 | Varelisa Cardiolipin Abs ScreenMID · Traditional | 10/02/1995SE |
| K951207 | Varelisa Histone AntibodiesLJM · Traditional | 04/17/1995SE |
| K951206 | Varelisa Parietal Cell AntibodiesMLE · Traditional | 04/17/1995SE |
| K951186 | Varelisa ANA-4 ScreenLJM · Traditional | 04/17/1995SE |
| K944334 | Varelisa Combined DNA Antibodies EiaLRM · Traditional | 04/17/1995SE |
Questions and answers
When was Varelisa Ana Profile cleared by the FDA?
Varelisa Ana Profile (K951205) received a 510(k) decision of Substantially Equivalent on April 17, 1995, 31 days after the submission was received.
What is the product code of K951205?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.