OMNIgene GUT Dx
FDA 510(k) clearance DEN200040 · decided 2021-11-03
Clearance details
- K-number
- DEN200040
- Device name
- OMNIgene GUT Dx
- Applicant
- DNA Genotek, Inc.
- Decision
- Unknown
- Date received
- 2020-06-15
- Decision date
- 2021-11-03
- Days to decision
- 506 days
- Clearance type
- Direct
- Product code
- QPO
- Device class
- 2
- Regulation number
- 866.2952
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Ottawa, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.