Helix Laboratory Platform
FDA 510(k) clearance DEN190035 · decided 2020-12-23
Clearance details
- K-number
- DEN190035
- Device name
- Helix Laboratory Platform
- Applicant
- Helix Opco, LLC
- Decision
- Unknown
- Date received
- 2019-08-02
- Decision date
- 2020-12-23
- Days to decision
- 509 days
- Clearance type
- Direct
- Product code
- QNC
- Device class
- 2
- Regulation number
- 866.6000
- Medical specialty
- Medical Genetics
- Advisory committee
- Medical Genetics
- Location
- Toronto, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.