510(k) K100818 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
ILLUMIGENE C. DIFFICILE, ILLUMIPRO-10 AND ILLUMIGENE C. DIFFICILE EXTERNAL CONTROL KIT, MODELS 280050, 610172, 279920
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Jul 9, 2010 |
| Received | Mar 23, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100818
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.