RNP Eia Test Kit
FDA 510(k) K935415 · David A. Fuccillo, Ph.D.
510(k) numberK935415
Submission
- Device name
- RNP Eia Test Kit
- Applicant
- David A. Fuccillo, Ph.D.
Washington, D.C., DC, US - Received
- November 9, 1993
- Decision date
- May 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K935413 | Ena Eia Test KitLLL · Traditional | 06/02/1994SE |
| K935419 | La Eia Test KitLLL · Traditional | 05/05/1994SE |
| K935418 | SCL-70 Eia Test KitLLL · Traditional | 05/05/1994SE |
| K935417 | JO-1 Eia Test KitLLL · Traditional | 05/05/1994SE |
| K940251 | Mitochondria Eia Test KitDBM · Traditional | 05/03/1994SE |
| K940253 | Histone Eia Test KitLJM · Traditional | 05/02/1994SE |
| K935416 | Ro Eia Test KitLJM · Traditional | 05/02/1994SE |
| K935414 | SM Eia Test KitLJM · Traditional | 05/02/1994SE |
Questions and answers
When was RNP Eia Test Kit cleared by the FDA?
RNP Eia Test Kit (K935415) received a 510(k) decision of Substantially Equivalent on May 2, 1994, 174 days after the submission was received.
What is the product code of K935415?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.