Premarket Notification 510(k) Submission Support
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.
Requirement of 510(K) submissions:
- 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.
If you would like more information or you wish to discuss this further, please contact us.
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.
Wound Care Test Methods
- Perfectus Biomed Shortlisted at the Medilink Healthcare Business Awards 2018
- Perfectus Biomed are attending the Cleaning Products Europe 2018 Conference
- Journal of Wound Care (JWC) Awards 2018
- Perfectus Biomed to attend the 2018 Biofilm Science and Technology Meetings
- Perfectus Biomed receives Act4Africa Certificate
- Perfectus Biomed donates to Act4Africa
- Christmas Opening Hours
- Regulatory Focus; Medical Device Regulation
- World Health Organisation publishes list of bacteria for which new antibiotics are needed
- Perfectus Biomed shortlisted for the Mornflake Oats Award for Innovation and the Outstanding Cheshire & Warrington Business Leader Award