# Sweden Diagnostics (Germany) GmbH

- Location (FDA's records): Freiburg, DE
- FDA decisions: 8 (2004–2005): 8 510(k) clearances
- Product codes: MST (2), LJM (2), MVM (2), LKP (1), MOB (1)
- Predicates its devices cite: 4 (1 its own); citations of its devices by later devices: 9 (1 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
- Pharmacia & Upjohn Co.: 3 (https://510kreport.com/company/pharmacia-upjohn)

## Firms that cite its devices most
- Phadia US, Inc.: 4 (https://510kreport.com/company/phadia-us)
- Biomedical Diagnostics (Bmd) SA: 3 (https://510kreport.com/company/biomedical-diagnostics-bmd)
- Bio-Rad Laboratories, Inc.: 1 (https://510kreport.com/company/bio-rad-laboratories)

## Its most-cited devices
- K042629: Varelisa SM Antibodies, Model 18296 (2004), cited by 2
- K041357: Varelisa Gliadin Igg Antibodies (2004), cited by 2
- K041173: Celikey Igg Itg Igg Antibodies, Model 17996 (2004), cited by 2
- K041354: Varelisa Gliadin Iga Antibodies Model #19848/19896 (2004), cited by 1
- K041040: Varelisa Mpo Anca, Model 17648/17696 (2004), cited by 1
- K041174: Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 (2004), cited by 1

## Recent decisions
- K050967: Varelisa Recombi CTD Screen, Model 13096 (Jun 28, 2005)
- K050625: Varelisa Recombi Ana Profile, Model 18496 (Apr 26, 2005)
- K042629: Varelisa SM Antibodies, Model 18296 (Dec 8, 2004)
- K041357: Varelisa Gliadin Igg Antibodies (Aug 2, 2004)
- K041173: Celikey Igg Itg Igg Antibodies, Model 17996 (Aug 2, 2004)
- K041174: Celikey TTG (Human, Recombinant) Iga Antibodies Model #18148/18196 (Jul 19, 2004)
- K041354: Varelisa Gliadin Iga Antibodies Model #19848/19896 (Jul 16, 2004)
- K041040: Varelisa Mpo Anca, Model 17648/17696 (Jun 16, 2004)

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