FDA applicant
Light Diagnostics
FDA records 19 decisions for Light Diagnostics (Temecula, CA) from 1993 to 1999: 19 510(k) clearances. Most are in product codes GOE (Antisera, Fluorescent, Poliovirus 1-3) and GNM (Antisera, Fluorescent, Coxsackievirus A 1-24…). Its devices cite 1 predicate, 1 of them its own earlier devices. 2 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Light Diagnostics’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Light Diagnostics since 2007.
Recalls per year
2in 2008
Class I Class II/III not classified
Planning a device like Light Diagnostics’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 “Light”
FDA records each applicant name separately; these may or may not be the same firm.