510(k) K190086 · PMN Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays

Cepheid Xpert Respiratory Control Panel

Applicant	Microbiologics, Inc., St. Cloud MN, US
Decision	Substantially Equivalent, Oct 7, 2019
Received	Jan 17, 2019
Type	Traditional
FDA record	Open on fda.gov

Recalls that name K190086

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.