Encore Ds-Dna
FDA 510(k) K923537 · Clark Laboratories, Inc.
510(k) numberK923537
Submission
- Device name
- Encore Ds-Dna
- Applicant
- Clark Laboratories, Inc.
Blairstown, NJ, US - Received
- July 16, 1992
- Decision date
- December 23, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
Other 510(k)s with product code LRM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K983422 | The Aptus (Automated) Applications of the DS DNA Elisa Test System Linked Immunosorbent…LRM · Traditional | Zeus Scientific, Inc. | 11/18/1998SE |
More from Zeus Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K980912 | Vca Igg Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980596 | Vca Igm Elisa Test SystemLSE · Traditional | 07/22/1998SE |
| K980598 | EBNA-1 Igm Elisa Test SystemLLM · Traditional | 05/01/1998SE |
| K973123 | Ea-D Igg Elisa Test SystemLSE · Traditional | 03/26/1998SE |
| K931543 | Encore Ena Combined EiaLLL · Traditional | 09/08/1993SE |
| K925826 | Encore Thyroglobulin Ige, Iga and Igm EiaJZO · Traditional | 01/26/1993SE |
| K921870 | Encore Sm/RnpLLL · Traditional | 12/01/1992SE |
| K921572 | Encore SMLLL · Traditional | 12/01/1992SE |
| K922340 | Encore Ss-BLLL · Traditional | 10/16/1992SE |
| K922157 | Encore Ss-ALLL · Traditional | 10/13/1992SE |
Questions and answers
When was Encore Ds-Dna cleared by the FDA?
Encore Ds-Dna (K923537) received a 510(k) decision of Substantially Equivalent on December 23, 1992, 160 days after the submission was received.
What is the product code of K923537?
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.