ClearanceBrief
510(k) DEN140005 ยท PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

LYRA DIRECT STREP ASSAY

ApplicantQuidel Corporation, Athens OH, US
DecisionUnknown, Apr 16, 2014
ReceivedMar 25, 2014
TypePost-NSE
FDA recordOpen on fda.gov

Recalls that name DEN140005

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.