Stat Engineering
Country not established
- Devices
- 1
What Stat Engineering makes
Stat Engineering manufactures diagnostic reagents, including the Perkin Elmer Model 91 Amylase Reagent, used for measuring amylase levels in clinical laboratory settings.
This product is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Perkin Elmer Model 91 Amylase Reagent Ref K801096
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Stat Engineering have in the registry?
The registry currently lists 1 device for Stat Engineering. Devices recorded under merged duplicate company entries are counted once.
Which registries list Stat Engineering's devices?
Among its 1 most recently registered device, Stat Engineering has devices listed in FDA 510(k) (1 device).
What risk classes do Stat Engineering's devices fall under?
Among its 1 most recently registered device, the classes recorded for Stat Engineering's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Stat Engineering in the registry?
The most recently registered devices listed for Stat Engineering include PERKIN ELMER MODEL 91 AMYLASE REAGENT.