510(k) K181156 ยท NJR Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test
Panther Fusion GBS Assay
| Applicant | Diagenode, Seraing, BE |
| Decision | Substantially Equivalent, Jul 27, 2018 |
| Received | May 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2025 | Hologic, Inc. Panther Fusion GBS Assay REF PRD-04484 Kit containing Panther Fusion GBS Reagent Cartridge IVD. Open, Classified |
NJR | None listed |
| Apr 6, 2022 | Hologic, Inc Panther Fusion GBS Assay Cartridges 96 Tests, Catalog Number: PRD-04484. in vitro diagnostic test for group b streptococcus. Open, Classified |
NJR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.