The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent Assay(Elisa)For the Det
FDA 510(k) K983422 · Zeus Scientific, Inc.
510(k) numberK983422
Submission
- Device name
- The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent Assay(Elisa)For the Det
- Applicant
- Zeus Scientific, Inc.
Branchburg, NJ, US - Received
- September 29, 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
- LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
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|---|---|---|---|
| K101319 | Immulisa Dsdna Antibody ElisaLRM · Traditional | Immco Diagnostics, Inc. | 12/09/2010SE |
| K083381 | Euroimmun Anti-Dsdna-Ncx Elisa (Igg)LRM · Traditional | Euroimmun Us, Inc. | 04/15/2009SE |
| K062183 | Farrzyme Human High Avidity Anti-Dsdna Enzyme Immunoassay KitLRM · Traditional | The Binding Site, Ltd. | 11/21/2006SE |
| K040811 | Varelisa Ssdna Antibodies, Model 14896LRM · Traditional | Pharmacia Deutschland GmbH | 05/13/2004SE |
| K001900 | Enzyme Immunoassay Anti-Ssdna Antibody TestLRM · Traditional | Helix Diagnostics, Inc. | 09/11/2000SE |
| K000477 | Mdi Ds-Dna TestLRM · Traditional | Micro Detect, Inc. | 03/01/2000SE |
| K994424 | Diamedix Is-Anti-Dsdna Test SystemLRM · Traditional | Diamedix Corp. | 02/18/2000SE |
| K993727 | Bindazyme Anti-Dsdna Eia KitLRM · Traditional | The Binding Site, Ltd. | 12/21/1999SE |
| K984396 | Liquichek Anti-Dsdna Control, Model 213LRM · Traditional | Bio-Rad | 12/18/1998SE |
| K980391 | Seraquest Anti-DsdnaLRM · Traditional | Quest Intl., Inc. | 04/24/1998SE |
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Questions and answers
When was The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent Assay(Elisa)For the Det cleared by the FDA?
The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent Assay(Elisa)For the Det (K983422) received a 510(k) decision of Substantially Equivalent on November 18, 1998, 50 days after the submission was received.
What is the product code of K983422?
The FDA product code is LRM – Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.