Data / Medical devices / Germany / AESKU.DIAGNOSTICS GmbH&Co.KG
AESKU.DIAGNOSTICS GmbH&Co.KG: FDA-registered device maker in WENDELSHEIM Rhineland-Palatinate, Germany, 16 510(k) clearances
AESKU.DIAGNOSTICS GmbH&Co.KG is registered with the FDA (registration 3003825930) in WENDELSHEIM Rhineland-Palatinate, Germany. It lists 16 device types. The FDA files 16 510(k) clearances under its listings, the newest dated March 23, 2018. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003825930
- Address
- Mikroforum Ring 2, WENDELSHEIM Rhineland-Palatinate, Germany, 55234
- Owner or operator
- Aesku.Diagnostics GmbH & Co. KG (9057973)
- Roles
- Manufacturer
- First device listed
- October 9, 2003
- Registered through
- 2026
- Brand names listed
- AESKULISA ANA HEp-2, AESKULISA dsDNA G, AESKULISA® ANA-8Pro, AESKULISA® ASCA, AESKULISA® Cardiolipin, AESKULISA® Cenp-B, AESKULISA® DGP, AESKULISA® ENA-6Pro and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 23, 2018 | K172461 | AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin | MOB | Substantially Equivalent | Aesku.Diagnostics GmbH & Co. KG | accessdata.fda.gov |
| February 16, 2018 | 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 | LSW | Substantially Equivalent | Aesku.Diagnostics GmbH & Co. KG | accessdata.fda.gov |
| July 28, 2016 | K153117 | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | DHN | Substantially Equivalent | Aesku Systems GmbH&Co.Kg | accessdata.fda.gov |
| December 5, 2013 | K132082 | AESKULISA DGP-A, AESKULISA DGP-G,AESKULISA DGP-CHECK | MST | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| October 15, 2012 | K120889 | AESKUSLIDES ANA HEP-2 | DHN | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| June 3, 2010 | K091859 | AESKU PR3 | MOB | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| February 23, 2010 | K091860 | AESKULISA MPO, MODEL 30-7303US | MOB | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| May 13, 2008 | K081251 | MODIFICATION TO AESKULISA DS DNA G | LSW | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| May 2, 2008 | K081104 | AESKULISA ANA HEP-2, REF 30-7115US | LKJ | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| December 13, 2006 | K062217 | AESKULSKA BETA2-GLYCO-A | MSV | Substantially Equivalent | Aesku, Inc. | accessdata.fda.gov |
| February 7, 2006 | K052439 | AESKULISA GLIA A AND AESKULISA GLIA G | MST | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| November 14, 2005 | K051492 | AESKULISA ASCA A | NBT | Substantially Equivalent | Aesku, Inc. | accessdata.fda.gov |
| June 1, 2005 | K042644 | AESKULISA TTG A AND AESKULISA TTG G | MVM | Substantially Equivalent | Aesku, Inc. | accessdata.fda.gov |
| July 14, 2004 | K041753 | AESKULISA ENA 6 S | LLL | Substantially Equivalent | Aesku Diagnostics | accessdata.fda.gov |
| May 12, 2004 | K040463 | AESKULISA CARDIOLIPIN AGM | MID | Substantially Equivalent | Aesku, Inc. | accessdata.fda.gov |
| December 16, 2003 | K032469 | AESKULISA ANA 8PRO | LLL | Substantially Equivalent | Aesku, Inc. | accessdata.fda.gov |
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Updated March 23, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.