LSW — Anti-Dna Antibody, Antigen And Control Class II
FDA Device Classification
Classification Details
- Product Code
- LSW
- Device Class
- Class II
- Regulation Number
- 866.5100
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K172348 | aesku.diagnostics gmbh and co. kg | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Dem | February 16, 2018 |
| K152013 | inova diagnostics | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Contro | April 11, 2016 |
| K081251 | aesku diagnostics | MODIFICATION TO AESKULISA DS DNA G | May 13, 2008 |
| K072393 | phadia us | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | December 7, 2007 |
| K060380 | biomedical diagnostics (bmd) | FIDIS DSDNA | May 2, 2006 |
| K041628 | aesku diagnostics | AESKULISA DS DNA G | October 14, 2004 |
| K921658 | immco diagnostics | ANTI-DSDNA ANTIBODY TEST | March 22, 1993 |
| K872085 | immunodiagnostics | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | September 1, 1987 |