OMNIgene GUT Dx— 510(k) DEN200040

Unknown

DNA Genotek, Inc.

FDA 510(k) clearance DEN200040 for OMNIgene GUT Dx, Unknown on 2021-11-03. Applicant: DNA Genotek, Inc.. Device class: 2.

Clearance details

Applicant: DNA Genotek, Inc.
Product code: Code QPO
Device class: Class 2
Regulation: 21 CFR 866.2952
Advisory panel: Microbiology
Date received: 2020-06-15
Decision date: 2021-11-03
Decision: Unknown
Clearance type: Direct
Location: Ottawa, CA

View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.