510(k) K121044 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
ILLUMIGENE GROUP B STREPTOCOCCUS CARROT BROTH CLAIM
| Applicant | Meridian Bioscience, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, May 1, 2012 |
| Received | Apr 6, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121044
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 19, 2025 | Meridian Bioscience Inc Meridian Bioscience, Group B Streptococcus, Catalog Number 480050, Nucleic Acid Amplification Test Assay Open, Classified |
NJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.