Pandex Laboratories, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Pandex Laboratories, Inc. makes
Pandex Laboratories, Inc. manufactures the Screen Machine System (SMS), a device used for automated screening and processing of samples, and the Fluorescence Concentration Analyzer (FCA), which quantifies fluorescent signals in biological or chemical samples.
The company’s products are classified as Class I medical devices under FDA regulations and are listed via the 510(k) pathway. Pandex Laboratories, Inc. is based in the United States.
Catalogue
Sms, Screen Machine System Ref K852240
Regimes: 510(k) Registry: 510(k)Fluorescence Concentration Analyzer (Fca) Ref K864699
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Pandex Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Pandex Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Pandex Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Pandex Laboratories, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Pandex Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Pandex Laboratories, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Pandex Laboratories, Inc. in the registry?
The most recently registered devices listed for Pandex Laboratories, Inc. include SMS, SCREEN MACHINE SYSTEM and FLUORESCENCE CONCENTRATION ANALYZER (FCA).