Our Accreditation for 510(k) Review

We are fully accredited by the Center for Devices and Radiological Health (CDRH) as a Third Party Reviewer. This program gives manufacturers of certain devices the opportunity to submit their 510(k) to private parties (Recognized Third Parties) identified by the FDA for review instead of submitting directly to CDRH. The purpose of the program is to improve the efficiency and timeliness of the 510(k) process.
We are accredited to review Class I and Class II IVD devices for Clinical Chemistry, Hematology, Immunology, Microbiology, Pathology, and Toxicology.

For details on our accreditation, access the FDA website

What is a 510(k)?

A 510(k) is the technical submission required by the United States Food and Drug Administration (FDA) to sell a medium-risk medical device or IVD in the United States. A 510(k) details technical, safety, and performance information about a medical device. The FDA must approve your device before you can legally sell or distribute it in the US.

A 510(k) is a premarket submission made to the FDA to demonstrate that a given device is at least as safe and effective (i.e., substantially equivalent) to a legally marketed device that is not subject to PMA (Premarket Application). Submitters must compare their device to one or more similar and legally marketed devices, commonly known as the "Predicate”, and make and support their substantial equivalence claims.

​For more information, click here to review FDA guidance