Helix Laboratory Platform— 510(k) DEN190035
UnknownHelix Opco, LLC
FDA 510(k) clearance DEN190035 for Helix Laboratory Platform, Unknown on 2020-12-23. Applicant: Helix Opco, LLC. Device class: 2.
Clearance details
- Applicant
- Helix Opco, LLC
- Product code
- Code QNC
- Device class
- Class 2
- Regulation
- 21 CFR 866.6000
- Advisory panel
- Medical Genetics
- Date received
- Decision date
- Decision
- Unknown
- Clearance type
- Direct
- Location
- Toronto, CA
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