Sweden Diagnostics (Germany) GmbH
GermanyFDA applicant, unverified
- Devices
- 8
Catalogue
Varelisa Recombi Ana Profile, Model 18496 Ref K050625
Regimes: 510(k) Registry: 510(k)Varelisa Gliadin Igg Antibodies Ref K041357
Regimes: 510(k) Registry: 510(k)Celikey Igg Itg Igg Antibodies, Model 17996 Ref K041173
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Varelisa Recombi Ctd Screen, Model 13096 Ref K050967
Regimes: 510(k) Registry: 510(k)Varelisa Mpo Anca, Model 17648/17696 Ref K041040
Regimes: 510(k) Registry: 510(k)Varelisa Sm Antibodies, Model 18296 Ref K042629
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Sweden Diagnostics (Germany) GmbH have in the registry?
The registry currently lists 8 devices for Sweden Diagnostics (Germany) GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sweden Diagnostics (Germany) GmbH's devices?
Among its 8 most recently registered devices, Sweden Diagnostics (Germany) GmbH has devices listed in FDA 510(k) (8 devices).
What risk classes do Sweden Diagnostics (Germany) GmbH's devices fall under?
Among its 8 most recently registered devices, the classes recorded for Sweden Diagnostics (Germany) GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Sweden Diagnostics (Germany) GmbH in the registry?
The most recently registered devices listed for Sweden Diagnostics (Germany) GmbH include VARELISA RECOMBI ANA PROFILE, MODEL 18496, VARELISA GLIADIN IGG ANTIBODIES, CELIKEY IGG ITG IGG ANTIBODIES, MODEL 17996 and CELIKEY TTG (HUMAN, RECOMBINANT) IGA ANTIBODIES MODEL #18148/18196.