Data / Medical devices / Canada / Micrylium Laboratories Inc.
Micrylium Laboratories Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 1 510(k) clearance
Micrylium Laboratories Inc. is registered with the FDA (registration 3002564560) in TORONTO Ontario, Canada. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 4, 1998. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3002564560
- Address
- 5000-M Dufferin Street, TORONTO Ontario, Canada, M3H5T5
- Owner or operator
- Micrylium Laboratories Inc. (9049100)
- Roles
- Manufacturer
- First device listed
- January 7, 2008
- Registered through
- 2026
- Brand names listed
- BioMERS, BioSON, BioSURF, BioTEXT, BioVAC, Lines
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleaner, Ultrasonic, Medical Instrument | FLG | 1 | Manufacturer | accessdata.fda.gov |
| Disinfectant, Medical Devices | LRJ | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Operative Dental | EIA | 1 | Manufacturer | accessdata.fda.gov |
| Unit, Suction Operatory | EBR | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 4, 1998 | K973765 | BIO-2000 | EIA | Substantially Equivalent | Micrylium Laboratories | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Operative Dental
- All makers of Disinfectant, Medical Devices
- All makers of Cleaner, Ultrasonic, Medical Instrument
- All makers of Unit, Suction Operatory
Updated November 4, 1998. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.