ClearanceBrief
510(k) K200748 ยท QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections

Visby Medical Sexual Health

ApplicantVisby Medical, San Jose CA, US
DecisionSubstantially Equivalent, Aug 26, 2021
ReceivedMar 23, 2020
TypeDual Track
FDA recordOpen on fda.gov

Recalls that name K200748

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.