# Wallac OY

- Location (FDA's records): Turku, FI
- FDA decisions: 24 (1992–2014): 22 510(k) clearances and 2 De Novo grants
- Names in FDA's records: Wallac OY (22); Wallac, Inc. (2)
- Product codes: JLX (5), CGZ (4), CDZ (2), NAK (2), PJI (1), CGI (1), KXT (1), JIA (1), JLW (1), CDX (1), CFL (1), KHO (1)
- Predicates its devices cite: 12 (5 its own); citations of its devices by later devices: 12 (5 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
- Pharmacia Diagnostics, Inc.: 2 (https://510kreport.com/company/pharmacia-diagnostics)
- Quantase, Ltd.: 1 (https://510kreport.com/company/quantase)
- Perkinelmer, Inc.: 1 (https://510kreport.com/company/perkinelmer)
- Cis Radiopharmaceuticals, Inc.: 1 (https://510kreport.com/company/cis-radiopharmaceuticals)
- Bio-Rad: 1 (https://510kreport.com/company/bio-rad)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Firms that cite its devices most
- Wallac Oy, A Subsidiary of Perkinelmer, Inc.: 3 (https://510kreport.com/company/wallac-oy-a-subsidiary-of-perkinelmer)
- Perkinelmer, Inc.: 2 (https://510kreport.com/company/perkinelmer)
- Wallac Oy, Subsidiary of Perkinelmer: 1 (https://510kreport.com/company/wallac-oy-subsidiary-of-perkinelmer)
- Neo-Genesis: 1 (https://510kreport.com/company/neo-genesis)

## Its most-cited devices
- K003668: Autodelfia Neonatal Irt Kit, Model B005-112 (2001), cited by 3
- K042425: Autodelfia Neonatal 17A-OH-Progesterone Kit (2004), cited by 3
- K935047: Auto Delfia (1994), cited by 2
- DEN140010: Perkinelmer Enlite Neonatal Trec Test System (2014), cited by 1
- K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B (2008), cited by 1
- K943416: Delfia Neonatal Thyroxine Kit (1995), cited by 1

## Recent decisions
- DEN140010: Perkinelmer Enlite Neonatal Trec Test System (Dec 15, 2014)
- K131284: GSP Neonatal Biotinidase Kit (Nov 14, 2013)
- K100682: GSP Neonatal 17A-OH-Progesterone Kit Model: 3305-001U (Jul 23, 2010)
- K081922: Autodelfia Neonatal 17A-OH-Progesterone Kit (Apr 16, 2009)
- K071649: Neonatal Total Galactose Kit; Neontal Total Galactose Kit, Models 3029-0010 and 3029-110B (Aug 7, 2008)
- K070889: Autodelfia Neonatal Irt L Kit, Model B022-112 (Apr 14, 2008)
- K050709: Resolve Hemoglobin Kit, JB-2 Staining System, Models FR-9120, FR-9400, FR-9360, FR-9367 (Mar 8, 2006)
- K050960: Modification to: Autodelfia Neonatal 17A-OH-Progesterone L Kit (Jul 11, 2005)

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