Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
FDA 510(k) clearance DEN180040 · decided 2018-11-30
Clearance details
- K-number
- DEN180040
- Device name
- Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit
- Applicant
- Meridian Bioscience, Inc.
- Decision
- Unknown
- Date received
- 2018-07-30
- Decision date
- 2018-11-30
- Days to decision
- 123 days
- Clearance type
- Direct
- Product code
- QDZ
- Device class
- 2
- Regulation number
- 866.3181
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Cincinnati, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.