Anti-Dsdna Antibody Test
FDA 510(k) K921658 · Immco Diagnostics, Inc.
510(k) numberK921658
Submission
- Device name
- Anti-Dsdna Antibody Test
- Applicant
- Immco Diagnostics, Inc.
Buffalo, NY, US - Received
- April 7, 1992
- Decision date
- March 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LSW – Anti-Dna Antibody, Antigen And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5100
- Specialty
- Immunology
Other 510(k)s with product code LSW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit…LSW · Traditional | Aesku.Diagnostics GmbH & Co. KG | 02/16/2018SE |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA ControlsLSW · Traditional | Inova Diagnostics, Inc. | 04/11/2016SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | Aesku Diagnostics | 05/13/2008SE |
| K072393 | Elia Dsdna Immunoassay, Model 14-5500-01, Elia Ana Control, Model 83-1004-01LSW · Traditional | Phadia US, Inc. | 12/07/2007SE |
| K060380 | Fidis DsdnaLSW · Traditional | Biomedical Diagnostics (Bmd) SA | 05/02/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | Aesku Diagnostics | 10/14/2004SE |
| K872085 | The Gamma-B Anti-Ds DNA Kit & Optional ControlsLSW · Traditional | Immunodiagnostics, Ltd. | 09/01/1987SE |
More from Immunodiagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172745 | ImmuGlo HEp-2 Elite IFADHN · Traditional | 06/05/2018SE |
| K172078 | ImmuLisa Enhanced RNA POL III Antibody ELISANYO · Traditional | 03/30/2018SE |
| K163133 | ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISADBM · Traditional | 08/08/2017SE |
| K163177 | ImmuLisa Enhanced Gliadin IgA Antibody ELISA, ImmuLisa Enhanced Gliadin IgG Antibody ELISAMST · Traditional | 07/28/2017SE |
| K162788 | ImmuLisa Enhanced B2GP1 IgA Antibody ELISA, ImmuLisa Enhanced B2GP1 IgG Antibody ELISA…MSV · Traditional | 06/19/2017SE |
| K151559 | ImmuLisa Enhanced Centromere Antibody ELISALJM · Traditional | 03/11/2016SE |
| K143736 | ImmuLisa Enhanced RF IgA Antibody ELISA, ImmuLisa Enhanced RF IgG Antibody ELISA…DHR · Traditional | 09/23/2015SE |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA…LLL · Traditional | 03/31/2015SE |
| K123713 | Immulisa Enhanced Celiac Fusion (Ttg/Dgp) Iga/Igg Antibody ElisaMVM · Traditional | 10/25/2013SE |
| K113020 | Immulisa Enhanced (TM) Cardiolipin Iga, Igg, Igm and Iga/Igg/Igm Antibody (Aca) ElisasMID · Traditional | 10/25/2012SE |
Questions and answers
When was Anti-Dsdna Antibody Test cleared by the FDA?
Anti-Dsdna Antibody Test (K921658) received a 510(k) decision of Substantially Equivalent on March 22, 1993, 349 days after the submission was received.
What is the product code of K921658?
The FDA product code is LSW – Anti-Dna Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.