Orgentec Anti-Scl 70 Pin Immuno Assay
FDA 510(k) K954814 · Orgentec
510(k) numberK954814
Submission
- Device name
- Orgentec Anti-Scl 70 Pin Immuno Assay
- Applicant
- Orgentec
Windham, NH, US - Received
- October 19, 1995
- Decision date
- April 18, 1996
- 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 |
|---|---|---|
| K954831 | Orgentec Anti-Rnp/Sm Pin Immuno AssayLKO · Traditional | 05/08/1996SE |
| K954830 | Orgentec Anti-Sm(Smith) Pin Immuno AssayLKP · Traditional | 05/08/1996SE |
| K954832 | Orgentec Anti-Ss-B(La) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954829 | Orgentec ANTI-JO-1 Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K954815 | Orgentec Anti-Ss-A(Ro) Pin Immuno AssayLJM · Traditional | 04/18/1996SE |
| K960274 | Orgentec Micro-Albumin Pin Eia AssayJIR · Traditional | 03/29/1996SE |
| K955134 | Orgentec Enascreen Elisa AssayLLL · Traditional | 03/20/1996SE |
| K955133 | Orgentec Enascreen Pin Immuno AssayLLL · Traditional | 03/20/1996SE |
| K953671 | Orgen Tec Anti-Dsdna Elisa AssayLRM · Traditional | 11/09/1995SE |
Questions and answers
When was Orgentec Anti-Scl 70 Pin Immuno Assay cleared by the FDA?
Orgentec Anti-Scl 70 Pin Immuno Assay (K954814) received a 510(k) decision of Substantially Equivalent on April 18, 1996, 182 days after the submission was received.
What is the product code of K954814?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.