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OMNIgene GUT Dx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200040
510(k) Type
Direct
Applicant
DNA Genotek Inc.
Country
Canada
FDA Decision
Deleted
Decision Date
11/3/2021
Days to Decision
506 days

OMNIgene GUT Dx

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
DEN200040
510(k) Type
Direct
Applicant
DNA Genotek Inc.
Country
Canada
FDA Decision
Deleted
Decision Date
11/3/2021
Days to Decision
506 days