Tomtec
Country not established
- Devices
- 2
What Tomtec makes
Tomtec manufactures automated systems for processing and analyzing blood samples, including the AUTOSTREAKER for automated bacterial streak plating and the GUAMSTAINER for Gram staining of microbiological cultures.
These devices are classified as Class I under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Autostreaker Ref K771569
Regimes: 510(k) Registry: 510(k)Guamstainer Ref K811697
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Tomtec have in the registry?
The registry currently lists 2 devices for Tomtec. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tomtec's devices?
Among its 2 most recently registered devices, Tomtec has devices listed in FDA 510(k) (2 devices).
What risk classes do Tomtec's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Tomtec's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Tomtec in the registry?
The most recently registered devices listed for Tomtec include AUTOSTREAKER and GUAMSTAINER.