510(k) K123423 ยท OZX Mycoplasma Pneumoniae Dna Assay System
ILLUMIGENE MYCOPLASAMA DNA AMPLIFICATION ASSAY, AND ILLUMIGENE MYCOPLASMA EXTERNAL CONTROLS KIT
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jun 5, 2013 |
| Received | Nov 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123423
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.