FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Revogene
K Number: K222779
·
Decision Jan 26, 2023
Classifications
1
FEI Numbers
78
Registration Numbers
78
Same Product Code
13
Applicant Total
38
Review Days
134
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Revogene
- K Number
- K222779
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.2570
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Meridian Bioscience, Inc.
- Date Received
- September 14, 2022
- Decision Date
- January 26, 2023
- Product Code
- OOI
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OOI | Real Time Nucleic Acid Amplification System | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OOI), ordered by most recent decision date.
Revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
revogene
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES MI System, ARIES HSV 1&2 Assay Cassettes-Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ARIES System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Meridian Bioscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K243922 | Revogene | Mar 20, 2025 | Substantially Equivalent |
| K230901 | Premier HpSA Flex (619096) | Jul 3, 2023 | Substantially Equivalent |
| K222829 | Curian® Shiga Toxin | Apr 17, 2023 | Substantially Equivalent |
| K220480 | Revogene | Jul 11, 2022 | Substantially Equivalent |
| K210976 | Curian Campy | Dec 23, 2021 | Substantially Equivalent |
| K192817 | Curian HpSA, Curian Analyzer | Mar 13, 2020 | Substantially Equivalent |
| DEN180040 | Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit | Nov 30, 2018 | Unknown |
| K182559 | PREMIER Platinum HpSA PLUS | Nov 5, 2018 | Substantially Equivalent |
| K163273 | TRU Legionella | Feb 21, 2017 | Substantially Equivalent |
| K160829 | illumigene Mycoplasma Direct DNA Amplification Assay, illumigene Mycoplasma Direct External Controls, illumipro-10 | Jun 13, 2016 | Substantially Equivalent |