ClearanceBrief
510(k) K231187 · QVF Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings

Nano-Check™ COVID-19 Antigen Test

ApplicantNano-Ditech Corporation, Cranbury NJ, US
DecisionSubstantially Equivalent, Jan 23, 2024
ReceivedApr 26, 2023
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K231187

No recall in the FDA data names this 510(k).

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.