Hamilton Thorne Incorporated
United StatesFDA applicant, unverified
- Devices
- 2
What Hamilton Thorne Incorporated makes
Hamilton Thorne Incorporated manufactures automated sperm washing systems, including the GM501 series with phenol red and gentamicin additives, as well as variants like SpermAir and SpermActive for sperm processing and preparation.
These devices are classified as Class II under FDA regulations and are authorised through the 510(k) pathway. The company is based in the United States.
Catalogue
GM501 Wash with Phenol Red and Gentamicin Ref K192503
Regimes: 510(k) Registry: 510(k)GM501 SpermAir and GM501 SpermActive Ref K192644
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hamilton Thorne Incorporated have in the registry?
The registry currently lists 2 devices for Hamilton Thorne Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hamilton Thorne Incorporated's devices?
Among its 2 most recently registered devices, Hamilton Thorne Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Hamilton Thorne Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hamilton Thorne Incorporated's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hamilton Thorne Incorporated in the registry?
The most recently registered devices listed for Hamilton Thorne Incorporated include GM501 Wash with Phenol Red and Gentamicin and GM501 SpermAir and GM501 SpermActive.