510(k) K110012 ยท OMN C. Difficile Nucleic Acid Amplification Test Assay
ILLUMIGENE C. DIFFICILE, AND ILLUMIPRO-10
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Feb 24, 2011 |
| Received | Jan 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110012
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, alethia c. Difficile, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
OMN | None listed |
| Jun 27, 2014 | Meridian Bioscience Inc illumipro-10 Incubator/Reader, Meridian Bioscience, Inc.
The illumipro-10 incubator/reader is designed to be used with illumigene Molecular Assays. The device incubates illumigene Test Devices and re Terminated |
OMN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.