# Aesku Diagnostics

- Location (FDA's records): Wendelsheim, Rheinland, DE
- FDA decisions: 11 (2004–2018): 11 510(k) clearances
- Names in FDA's records: Aesku Diagnostics (9); Aesku.Diagnostics GmbH & Co. KG (2)
- Product codes: LSW (3), MOB (3), MST (2), LKJ (1), DHN (1), LLL (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms that cite its devices most
- Euroimmun Us, Inc.: 2 (https://510kreport.com/company/euroimmun-us)
- Grifols USA, LLC: 1 (https://510kreport.com/company/grifols-usa)

## Its most-cited devices
- K081104: Aeskulisa Ana Hep-2, Ref 30-7115US (2008), cited by 2
- K052439: Aeskulisa Glia a and Aeskulisa Glia G (2006), cited by 1

## Recent decisions
- K172461: AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin (Mar 23, 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 (Feb 16, 2018)
- K132082: Aeskulisa DGP-a, Aeskulisa DGP-G,Aeskulisa DGP-Check (Dec 5, 2013)
- K120889: Aeskuslides Ana Hep-2 (Oct 15, 2012)
- K091859: Aesku PR3 (Jun 3, 2010)
- K091860: Aeskulisa Mpo, Model 30-7303US (Feb 23, 2010)
- K081251: Modification to Aeskulisa DS Dna G (May 13, 2008)
- K081104: Aeskulisa Ana Hep-2, Ref 30-7115US (May 2, 2008)

Source page: https://510kreport.com/company/aesku-diagnostics