ClearanceBrief
510(k) K133474 ยท PSZ Devices Detecting Influenza A, B, And C Virus Antigens

BIOSIGN FLU A + B, STATUS FLU A & B

ApplicantPrinceton BioMeditech Corp., Monmouth Junction NJ, US
DecisionSubstantially Equivalent, Dec 10, 2013
ReceivedNov 12, 2013
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K133474

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.