510(k) K172582 · MOB Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

EUROIMMUN IFA Granulocyte Mosaic EUROPattern and EUROIMMUN EUROPLUS Granulocyte Mosaic EUROPattern

Applicant	Euroimmun Us, Inc., Mountain Lakes NJ, US
Decision	Substantially Equivalent, May 24, 2018
Received	Aug 28, 2017
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K172582

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.