FDA 510(k) Applications for Medical Device Product Code "LSW"
|
FDA 510(k) Number | Applicant | Device Name | Decision Date |
K172348 | Aesku Diagnostics GmbH & Co. KG | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | 02/16/2018 |
K041628 | AESKU.DIAGNOSTICS | AESKULISA DS DNA G | 10/14/2004 |
K081251 | AESKU.DIAGNOSTICS | MODIFICATION TO AESKULISA DS DNA G | 05/13/2008 |
K060380 | BIOMEDICAL DIAGNOSTICS (BMD) SA | FIDIS DSDNA | 05/02/2006 |
K152013 | INOVA DIAGNOSTICS, INC. | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | 04/11/2016 |
K072393 | PHADIA US INC. | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | 12/07/2007 |