# Preanalytix GmbH

- Location (FDA's records): Hombrechtikon, CH
- FDA decisions: 4 (2005–2023): 3 510(k) clearances and 1 De Novo grant
- Product codes: PJE (2), NTW (2)
- Predicates its devices cite: 3 (2 its own); citations of its devices by later devices: 4 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Becton Dickinson Vacutainer Systems: 1 (https://510kreport.com/company/becton-dickinson-vacutainer-systems)

## Firms that cite its devices most
- Asuragen, Inc.: 2 (https://510kreport.com/company/asuragen)

## Its most-cited devices
- DEN050003: Paxgene Blood Rna System (2005), cited by 2
- K142821: PAXgene Blood DNA Tube (2015), cited by 1
- K082150: Modification to Paxgene Blood Rna System (2009), cited by 1

## Recent decisions
- K231469: PAXgene® Blood DNA Tube (Jun 21, 2023)
- K142821: PAXgene Blood DNA Tube (Sep 9, 2015)
- K082150: Modification to Paxgene Blood Rna System (Feb 4, 2009)
- DEN050003: Paxgene Blood Rna System (Apr 18, 2005)

Source page: https://510kreport.com/company/preanalytix