# Phadia AB

- Location (FDA's records): Uppsala, SE
- FDA decisions: 34 (2007–2026): 34 510(k) clearances
- Names in FDA's records: Phadia AB (33); Phadia GmbH (1)
- Product codes: DHB (16), DGC (2), LLL (2), LKP (2), LJM (2), OYL (1), MSV (1), DBM (1), MQA (1), DHR (1), NYO (1), MOB (1)
- Predicates its devices cite: 53 (5 its own); citations of its devices by later devices: 7 (5 its own)
- Recalls linked to its devices: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Phadia US, Inc.: 16 (https://510kreport.com/company/phadia-us)
- Pharmacia Diagnostics, Inc.: 13 (https://510kreport.com/company/pharmacia-diagnostics)
- Pharmacia, Inc.: 10 (https://510kreport.com/company/pharmacia)
- Inova Diagnostics, Inc.: 5 (https://510kreport.com/company/inova-diagnostics)
- Pharmacia & Upjohn Co.: 3 (https://510kreport.com/company/pharmacia-upjohn)
- Sweden Diagnostics (Us), Inc.: 1 (https://510kreport.com/company/sweden-diagnostics-us)

## Firms that cite its devices most
- Phadia US, Inc.: 1 (https://510kreport.com/company/phadia-us)
- Kenota, Inc.: 1 (https://510kreport.com/company/kenota)

## Its most-cited devices
- K101251: Immunocap Allergen D202, Allergen Component Nder P 1, House Dust Mite, Immunocap Allergen D203, Allergen (2011), cited by 1
- K133404: Immunocap Total Ige: Conjugate, Anti-Ige, Calibrators, Curve Controls, Control LMH (2014), cited by 1
- K202540: EliA Rib-P (2021), cited by 1
- K202541: EliA RNA Pol III (2021), cited by 1
- K081830: Immunocap Rapid Inhalant Profile , Immunocap Rapid Reader, Immunocap Rapid Reader Check Device, and Immunocap Rapid QC1 (2009), cited by 1
- K190710: EliA SymphonyS Immunoassay (2019), cited by 1

## Recent decisions
- K253367: EliA CTD 13 Screen (Jun 25, 2026)
- K212181: ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat, ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat, ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed (Aug 3, 2022)
- K210902: EliA Ro52, EliA Ro60 (Jul 27, 2022)
- K202540: EliA Rib-P (Sep 13, 2021)
- K202541: EliA RNA Pol III (Sep 13, 2021)
- K202067: EliA SmDP-S (Jul 14, 2021)
- K200279: ImmunoCAP Allergen o215, Component nGal-alpha-1,3-Gal (alpha-Gal) Thyroglobulin, bovine (May 1, 2020)
- K190710: EliA SymphonyS Immunoassay (Nov 29, 2019)

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