# Phadia US, Inc.

- Location (FDA's records): Portage, MI
- FDA decisions: 22 (2006–2015): 21 510(k) clearances and 1 De Novo grant
- Product codes: DHB (4), MID (2), MVM (2), MST (2), LKP (1), LJM (1), LLL (1), DBM (1), MSV (1), LKO (1), JNL (1), LKJ (1)
- Predicates its devices cite: 40 (0 its own); citations of its devices by later devices: 17 (0 its own)
- Recalls linked to its devices: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Inova Diagnostics, Inc.: 11 (https://510kreport.com/company/inova-diagnostics)
- Pharmacia & Upjohn Co.: 7 (https://510kreport.com/company/pharmacia-upjohn)
- Pharmacia Deutschland GmbH: 5 (https://510kreport.com/company/pharmacia-deutschland)
- Sweden Diagnostics (Germany) GmbH: 4 (https://510kreport.com/company/sweden-diagnostics-germany)
- Elias U.S.A., Inc.: 4 (https://510kreport.com/company/elias-usa)
- Pharmacia Diagnostics, Inc.: 3 (https://510kreport.com/company/pharmacia-diagnostics)
- Pharmacia, Inc.: 3 (https://510kreport.com/company/pharmacia)
- Wieslab AB: 1 (https://510kreport.com/company/wieslab)

## Firms that cite its devices most
- Phadia AB: 16 (https://510kreport.com/company/phadia)
- Reprocessing Products Corporation (Rpc): 1 (https://510kreport.com/company/reprocessing-products-rpc)

## Its most-cited devices
- K132631: Eia SMDP Immunoassay (2014), cited by 2
- DEN120001: Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase (2012), cited by 2
- K131821: Elia (TM) Cardiolipin Iga Immunoassay (2013), cited by 1
- K062583: Elia Celikey Igg Well, Model 14-5518-01, Elia Celiac Control, Model 83-1011-01 (2006), cited by 1
- K072149: Elia Symphony Immunoassay, Ana Control, Model 14-55508-01,83-1004-01 (2008), cited by 1
- K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250 (2015), cited by 1

## Recent decisions
- K141375: Elia M2; Immunoassay, Positive Control 100, Positive Control 250 (Feb 13, 2015)
- K140225: Elia PR3S Immunoassay, Elia Mpos Immunoassay, Elia GBM Immunoassay, Elia Anca/GBM Positive Control 100, Elia Anca/GBM PO (Oct 27, 2014)
- K132631: Eia SMDP Immunoassay (Aug 29, 2014)
- K131821: Elia (TM) Cardiolipin Iga Immunoassay (Dec 23, 2013)
- K122197: Automated in Vitro Quantitative Assay for the Measurement of Allergen Specific Ige Antibodies (Aug 28, 2013)
- K113841: Immunocap Allergen Components Bundle (Sep 13, 2012)
- K112414: Elia  B2-Glycoprotein I Iga Immunoassay (Jun 22, 2012)
- DEN120001: Immunocap Tryptase, Calibrators, Curve Control, Conjugate 50, Calibrator Strip, Curve Control Strip, Anti-Tryptase (Feb 15, 2012)

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