510(k) K152800 ยท OZX Mycoplasma Pneumoniae Dna Assay System
illumigene Mycoplasma DNA Amplification Assay
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Oct 23, 2015 |
| Received | Sep 28, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K152800
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.