510(k) K133673 ยท OZZ Bordetella Pertussis Dna Assay System
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Mar 25, 2014 |
| Received | Nov 29, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133673
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.