ClearanceBrief
510(k) K060700 ยท MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

EUROIMMUN PR3 ELISA KIT. EUROIMMUN MPO ELISA KIT.

ApplicantEuroimmun Us, LLC, Boonton Twp NJ, US
DecisionSubstantially Equivalent, Sep 8, 2006
ReceivedMar 15, 2006
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K060700

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.