510(k) K180509 · LCP Assay, Glycosylated Hemoglobin

Quo-Test A1c System

Applicant	Ekf-Diagnostic GmbH, Barleben, DE
Decision	Substantially Equivalent, Feb 16, 2019
Received	Feb 27, 2018
Type	Dual Track
FDA record	Open on fda.gov

Recalls that name K180509

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.