The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) For.
FDA 510(k) K983378 · Zeus Scientific, Inc.
510(k) numberK983378
Submission
- Device name
- The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) For.
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- September 25, 1998
- Decision date
- November 18, 1998
- 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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| 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 |
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Questions and answers
When was The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) For. cleared by the FDA?
The Aptus (Automated) Application of the Ana Screen Elisa Test System. an Enzyme Linked Immunosorbent Assay (Elisa) For. (K983378) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 54 days after the submission was received.
What is the product code of K983378?
The FDA product code is LJM – Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls, a Class II (moderate risk) device regulated under 21 CFR 866.5100.