Orgentec ANTI-JO-1 Elisa
FDA 510(k) K962053 · American Laboratory Products Co., Ltd.
510(k) numberK962053
Submission
- Device name
- Orgentec ANTI-JO-1 Elisa
- Applicant
- American Laboratory Products Co., Ltd.
Windham, NH, US - Received
- May 28, 1996
- Decision date
- November 15, 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 |
|---|---|---|
| K012576 | CIC-C1Q EiaDAK · Traditional | 01/29/2002SE |
| K011415 | Alpco Milenia Anti-Tg EiaJZO · Traditional | 05/30/2001SE |
| K011201 | Alpco Milenia Anti-Tpo ElisaJZO · Traditional | 05/24/2001SE |
| K974702 | Orgentec ANTI-PR3 (C-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K974701 | Orgentec Anti-Mpo (P-Anca) ElisaMOB · Traditional | 02/17/1998SE |
| K972190 | Thyroglobulin Assay SystemJZO · Traditional | 07/14/1997SE |
| K970932 | Orgentec Micro-Albumin Eia AssayJIR · Traditional | 04/08/1997SE |
| K962062 | Orgentec Anti-Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962057 | Orgentec Anti-Rnp/Sm ElisaLJM · Traditional | 11/18/1996SE |
| K962055 | Orgentec Anti-Scl 70 ElisaLJM · Traditional | 11/15/1996SE |
Questions and answers
When was Orgentec ANTI-JO-1 Elisa cleared by the FDA?
Orgentec ANTI-JO-1 Elisa (K962053) received a 510(k) decision of Substantially Equivalent on November 15, 1996, 171 days after the submission was received.
What is the product code of K962053?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.