Accutex Sle Latex Test
FDA 510(k) K924248 · J.S. Medical Assoc.
510(k) numberK924248
Submission
- Device name
- Accutex Sle Latex Test
- Applicant
- J.S. Medical Assoc.
Natick, MA, US - Received
- August 24, 1992
- Decision date
- November 2, 1992
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K932752 | Visi-SpotJTO · Traditional | 11/05/1993SE |
| K932688 | Eye Spot Im TestKTN · Traditional | 09/08/1993SE |
| K932180 | Eye Spot CRP TestDCN · Traditional | 08/23/1993SE |
| K932551 | Accutex Im Latex TestKTN · Traditional | 08/09/1993SE |
| K926112 | Accutex Beta-Hcg TestJHJ · Traditional | 07/28/1993SE |
| K924332 | Accutex CRP Latex TestDCK · Traditional | 12/07/1992SE |
| K924247 | Accutex Aso Latex TestGTQ · Traditional | 12/07/1992SE |
| K924036 | Accutex Rheumatiod Factor (RF) Latex TestDHR · Traditional | 12/01/1992SE |
| K924037 | Accutex Im RBC TestKTN · Traditional | 11/02/1992SE |
| K912717 | J&S Uibc ReagentsJMO · Traditional | 09/25/1991SE |
Questions and answers
When was Accutex Sle Latex Test cleared by the FDA?
Accutex Sle Latex Test (K924248) received a 510(k) decision of Substantially Equivalent on November 2, 1992, 70 days after the submission was received.
What is the product code of K924248?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.