Princeton BioMeditech Corp. - FDA 510(k) Cleared Devices

Princeton BioMeditech Corp., is a world leader in rapid, point-of-care diagnostic products. The company develops and manufactures high-quality tests for consumer in-home use and professional on-site applications, with a manufacturing facility in Monmouth Junction, New Jersey. PBM offers an extensive menu of over 70 different rapid diagnostic tests across multiple therapeutic areas.

The company has received 72 FDA 510(k) clearances from 72 total submissions since 1994, with no denied submissions on record. PBM specializes in toxicology devices, including rapid drug-of-abuse screening tests. The company's latest FDA 510(k) clearance was in 2025, demonstrating continued regulatory activity and product innovation.

PBM's product portfolio spans fertility diagnostics, infectious disease testing, cardiac markers, tumor markers, food and environmental diagnostics, and veterinary diagnostics. The company operates as a registered FDA Medical Device Establishment under current Good Manufacturing Practices (cGMP) and maintains ISO 13485:2016 certification. Products carry FDA 510(k) clearance in the U.S., CMDCAS approval in Canada, and CE marking in the European Union.

Explore the complete list of device names, product codes, and clearance dates in the 510(k) database to review PBM's full regulatory history and cleared device portfolio.