ClearanceBrief
510(k) K153150 ยท PIV Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use

AUTOLoader, and NOVA view with models: ALDR1000, AND NV2000

ApplicantInova Diagnostics, Inc., San Diego CA, US
DecisionSubstantially Equivalent, Nov 24, 2015
ReceivedNov 2, 2015
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K153150

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.