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) K172348 · Aesku.Diagnostics GmbH & Co. KG
510(k) numberK172348
Submission
- 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
Wendeslheim, DE - Received
- August 3, 2017
- Decision date
- February 16, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K921658 | Anti-Dsdna Antibody TestLSW · Traditional | Immco Diagnostics, Inc. | 03/22/1993SE |
| K872085 | The Gamma-B Anti-Ds DNA Kit & Optional ControlsLSW · Traditional | Immunodiagnostics, Ltd. | 09/01/1987SE |
More from Immunodiagnostics, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA FormalinMOB · Traditional | 03/23/2018SE |
| K132082 | Aeskulisa Dgp-A, Aeskulisa Dgp-G,Aeskulisa Dgp-CheckMST · Traditional | 12/05/2013SE |
| K120889 | Aeskuslides Ana HEP-2DHN · Traditional | 10/15/2012SE |
| K091859 | Aesku PR3MOB · Traditional | 06/03/2010SE |
| K091860 | Aeskulisa Mpo, Model 30-7303USMOB · Traditional | 02/23/2010SE |
| K081251 | Modification to Aeskulisa DS DNA GLSW · Special | 05/13/2008SE |
| K081104 | Aeskulisa Ana HEP-2, Ref 30-7115USLKJ · Traditional | 05/02/2008SE |
| K052439 | Aeskulisa Glia a and Aeskulisa Glia GMST · Traditional | 02/07/2006SE |
| K041628 | Aeskulisa DS DNA GLSW · Traditional | 10/14/2004SE |
| K041753 | Aeskulisa Ena 6 SLLL · Traditional | 07/14/2004SE |
Questions and answers
When was AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 cleared by the FDA?
AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x5, AESKUSLIDES nDNA (Crithidia luciliae) Bulk kit x10 (K172348) received a 510(k) decision of Substantially Equivalent on February 16, 2018, 197 days after the submission was received.
What is the product code of K172348?
The FDA product code is LSW – Anti-Dna Antibody, Antigen And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5100.