Micrylium Laboratories
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Micrylium Laboratories makes
Micrylium Laboratories manufactures the BIO-2000, a Class I medical device designed for biological sample processing or analysis, though specific applications are not detailed.
The BIO-2000 is regulated under the FDA’s 510(k) pathway as a Class I device and is listed in the FDA’s 510(k) database. The company is based in the United States.
Catalogue
Bio-2000 Ref K973765
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Micrylium Laboratories Inc. TORONTO Ontario · CA FEI 3002564560
Frequently asked questions
How many devices does Micrylium Laboratories have in the registry?
The registry currently lists 1 device for Micrylium Laboratories. Devices recorded under merged duplicate company entries are counted once.
Which registries list Micrylium Laboratories's devices?
Among its 1 most recently registered device, Micrylium Laboratories has devices listed in FDA 510(k) (1 device).
What risk classes do Micrylium Laboratories's devices fall under?
Among its 1 most recently registered device, the classes recorded for Micrylium Laboratories's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Micrylium Laboratories in the registry?
The most recently registered devices listed for Micrylium Laboratories include BIO-2000.
Which FDA establishments are linked to Micrylium Laboratories?
1 FDA establishment is linked to Micrylium Laboratories in the registry; they are listed on the company page.