510(k) DEN200040
- Device
- OMNIgene GUT Dx
- Applicant
- DNA Genotek, Inc.
- 510(k) number
- DEN200040
- Product code
- QPO
- Decision
- Unknown (DENG)
- Decision date
- 2021-11-03
- Date received
- 2020-06-15
- Regulation
- 866.2952
- Classification name
- Device To Preserve And Stabilize Relative Abundances Of Microbial Nucleic Acids In Clinical Samples
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Austin Udocor
- Address
- 3000 - 500 Palladium Dr. Ottawa CA K2V 1C2 K2V 1C2
FDA Registration Numbers#
- 3004142665
- 3022474803
- 3003742580
Source Documents#
510(k) summary PDF not indicated by FDA