AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
FDA 510(k) clearance K172348 · decided 2018-02-16
Clearance details
- K-number
- K172348
- Device name
- AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10
- Applicant
- Aesku.Diagnostics GmbH & Co. KG
- Decision
- Substantially Equivalent
- Date received
- 2017-08-03
- Decision date
- 2018-02-16
- Days to decision
- 197 days
- Clearance type
- Traditional
- Product code
- LSW
- Device class
- 2
- Regulation number
- 866.5100
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Wendeslheim, DE
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QUANTA Flash dsDNA, QUANTA Flash dsDNA Calibrators and QUANTA Flash dsDNA Controls (K152013) | Inova Diagnostics, Inc. | 2016-04-11 |
| MODIFICATION TO AESKULISA DS DNA G (K081251) | Aesku Diagnostics | 2008-05-13 |
| ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01 (K072393) | Phadia US, Inc. | 2007-12-07 |
| FIDIS DSDNA (K060380) | Biomedical Diagnostics (Bmd) SA | 2006-05-02 |
| AESKULISA DS DNA G (K041628) | Aesku Diagnostics | 2004-10-14 |
| ANTI-DSDNA ANTIBODY TEST (K921658) | Immco Diagnostics, Inc. | 1993-03-22 |
| THE GAMMA-B ANTI-DS DNA KIT & OPTIONAL CONTROLS (K872085) | Immunodiagnostics, Ltd. | 1987-09-01 |
Recalls involving this device
No recalls on record reference this clearance.