FDA applicant
Princeton BioMeditech Corp.
FDA records 72 decisions for Princeton BioMeditech Corp. (Monmouth Junction, NJ) from 1994 to 2025: 72 510(k) clearances. Most are in product codes DIO (Enzyme Immunoassay, Cocaine And Cocaine…) and DIS (Enzyme Immunoassay, Barbiturate). Its devices cite 22 predicates, 13 of them its own earlier devices. 5 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Princeton BioMeditech Corp.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
1in 2024
Class I Class II/III not classified
Planning a device like Princeton BioMeditech Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Princeton”
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