Antimicrobial Medical Device Testing for FDA 510k
Antimicrobial Test Laboratories is the laboratory for testing antimicrobial medical devices for FDA 510k submissions. The lab is fully FDA GLP compliant. Most importantly, we are antimicrobial testing experts and will take your 510k submission seriously.
While other labs say "...let's power up this study," Antimicrobial Test Labs asks, "How can we run the most cost-effective, elegant and scientifcally defensible study to meet FDA's high standards?" Then we get right to it, working with our clients to nail down the study design and reduce study cost wherever possible. Finally we draft a clear protocol and schedule and report studies at a rapid clip.
We take great pride in the large data packs we have created that have gone to FDA in support of 510k submissions, and we have a number of past and present clients pleased enough with our service to recommend us to their associates.
The laboratory has tested antimcrobial devices ranging from ports to wound dressings to catheters, and is able to test the antimicrobial efficacy of surgical masks, and countless other device types.
If your firm is interested in GLP testing to support and FDA 510k submission, please contact the laboratory. Your firm's 510k antimicrobial efficacy studies will get our full attention and the full benefit of our expertise. Ultimately, if your device proves efficacious, the goal is FDA approval. Antimicrobial Test Labs is well suited to get you there as fast and cost-effectively as possible.