FDA Product Code
FDA Product Code LSW — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Immunology
- 21 CFR Citation
- 866.5100
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 | Aesku.Diagnostics GmbH & Co. KG | 2018-02-16 | Traditional | PDF ↗ |
| K152013 | QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls | Inova Diagnostics, Inc. | 2016-04-11 | Traditional | PDF ↗ |
| K081251 | MODIFICATION TO AESKULISA DS DNA G | Aesku Diagnostics | 2008-05-13 | Special | PDF ↗ |
| K072393 | ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 | Phadia US, Inc. | 2007-12-07 | Traditional | PDF ↗ |
| K060380 | FIDIS DSDNA | Biomedical Diagnostics (Bmd) SA | 2006-05-02 | Traditional | PDF ↗ |
| K041628 | AESKULISA DS DNA G | Aesku Diagnostics | 2004-10-14 | Traditional | PDF ↗ |
| K921658 | ANTI-DSDNA ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-03-22 | Traditional | PDF ↗ |
| K872085 | THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS | Immunodiagnostics, Ltd. | 1987-09-01 | Traditional | PDF ↗ |
Product code LSW · Class II · Immunology. Data: openFDA.