Company ยท DE
Aesku Diagnostics
FDA 510(k) clearances and medical device recalls filed under this name, 2004 to 2018. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LSW | Anti-Dna Antibody, Antigen And Control | 3 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 3 |
| MST | Antibodies, Gliadin | 2 |
| DHN | Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 23, 2018 | K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin Aesku.Diagnostics GmbH & Co. KG, DE | MOB |
| Feb 16, 2018 | K172348 | AESKUSLIDES nDNA (Crithidia luciliae), AESKUSLIDES nDNA (Crithidia luciliae) Demo Kit, AESKUSLIDES nDNA (Crithidia lucil Aesku.Diagnostics GmbH & Co. KG, DE | LSW |
| Dec 5, 2013 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK Aesku Diagnostics, DE | MST |
| Oct 15, 2012 | K120889 | AESKUSLIDES ANA HEP-2 Aesku Diagnostics | DHN |
| Jun 3, 2010 | K091859 | AESKU PR3 Aesku Diagnostics, DE | MOB |
| Feb 23, 2010 | K091860 | AESKULISA MPO, MODEL 30-7303US Aesku Diagnostics, DE | MOB |
| May 13, 2008 | K081251 | MODIFICATION TO AESKULISA DS DNA G Aesku Diagnostics, DE | LSW |
| May 2, 2008 | K081104 | AESKULISA ANA HEP-2, REF 30-7115US Aesku Diagnostics, DE | LKJ |
| Feb 7, 2006 | K052439 | AESKULISA GLIA A AND AESKULISA GLIA G Aesku Diagnostics | MST |
| Oct 14, 2004 | K041628 | AESKULISA DS DNA G Aesku Diagnostics | LSW |
| Jul 14, 2004 | K041753 | AESKULISA ENA 6 S Aesku Diagnostics | LLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||