K243922
- 510(k) number
- K243922
- Device name
- Revogene
- Applicant
- Meridian Bioscience, Inc. OH · US
- Product code
- OOI — Real Time Nucleic Acid Amplification System
- Decision date
- 2025-03-20
- Date received
- 2024-12-20
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K243922.pdf
Official FDA record: K243922
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.