Helmer Labs, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
Catalogue
DeviceDevice · Authorizations Verified Status Regime Registry Class
Platelet Agitator Ref K812533
Regimes: 510(k) Registry: 510(k)Platelet Agitator Ref K770830
Regimes: 510(k) Registry: 510(k)Hematic Blood Mixer Ref K802608
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Helmer Labs, Inc. have in the registry?
The registry currently lists 3 devices for Helmer Labs, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helmer Labs, Inc.'s devices?
Among its 3 most recently registered devices, Helmer Labs, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Helmer Labs, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Helmer Labs, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Helmer Labs, Inc. in the registry?
The most recently registered devices listed for Helmer Labs, Inc. include PLATELET AGITATOR and HEMATIC BLOOD MIXER.