Bartels, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Bartels, Inc. makes
Bartels, Inc. manufactures laboratory instruments, including the ZYMMUNE AUTOREADER-F, a fluorescence microplate reader designed for automated detection and analysis of fluorescence signals in microplate assays. The company also produces the H292, a device intended for specific in vitro diagnostic applications.
The company’s portfolio is classified under Class I medical devices in the US, with devices authorised through the FDA’s 510(k) clearance process. These products are listed in the FDA’s regulatory database and are intended for use within the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
H292 Ref K942820
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bartels, Inc. have in the registry?
The registry currently lists 2 devices for Bartels, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bartels, Inc.'s devices?
Among its 2 most recently registered devices, Bartels, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Bartels, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Bartels, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Bartels, Inc. in the registry?
The most recently registered devices listed for Bartels, Inc. include ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER and H292.