Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit— 510(k) DEN180040
UnknownMeridian Bioscience, Inc.
FDA 510(k) clearance DEN180040 for Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit, Unknown on 2018-11-30. Applicant: Meridian Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Meridian Bioscience, Inc.
- Product code
- Code QDZ
- Device class
- Class 2
- Regulation
- 21 CFR 866.3181
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Cincinnati, OH, US
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