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Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180040
510(k) Type
Direct
Applicant
Meridian Bioscience, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
11/30/2018
Days to Decision
123 days

Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN180040
510(k) Type
Direct
Applicant
Meridian Bioscience, Inc.
Country
United States
FDA Decision
Deleted
Decision Date
11/30/2018
Days to Decision
123 days