Perfectus Biomed support companies with their data generation portfolio in order to support their 510(k) submission.
The FDA require 510(k) premarket submissions for new devices that are not subject to Post Market Approval (PMA). The submission demonstrates that a device to be marketed is at least as safe and effective as a legally marketed device (21 CFR 807.92(a)(3)). Submitters must compare their device to one or more similar legally marketed devices.
When a 510(K) submission is required:
- When commercial distribution of a new device is occurring for the first time.
- When there is a change/modification to an existing legally marketed device that may affect its safety or effectiveness.
Our library of test organism includes…
Choose from our library of test organism including standard reference strains, clinical isolates and environmental isolates. Single or mixed species assays containing:
Enterococcus faecium (VRE)
Staphylococcus aureus (MRSA and MSSA)
WHO Priority organisms.
Other- please ask.
Get in Touch
We are happy to help with your microbiological requirements and with any other queries you may have.