510(k) K170558 ยท OOI Real Time Nucleic Acid Amplification System
revogene
| Applicant | Genepoc, Inc., Quebec, CA |
| Decision | Substantially Equivalent, May 25, 2017 |
| Received | Feb 24, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170558
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2022 | Meridian Bioscience Inc Revogene, Catalog no. 610210. IVD test instrument Open, Classified |
OOI | None listed |
| Feb 15, 2022 | Meridian Bioscience Inc Revogene, For In Vitro Diagnostic use in performing nucleic acid testing in clinical laboratories.
Meridian branded Revogene: Catalog Number 610210
GenePOC branded Revogene: Catalog Number 130840 Open, Classified |
OOI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.