510(k) DEN190035
- Device
- Helix Laboratory Platform
- Applicant
- Helix Opco, LLC
- 510(k) number
- DEN190035
- Product code
- QNC
- Decision
- Unknown (DENG)
- Decision date
- 2020-12-23
- Date received
- 2019-08-02
- Regulation
- 866.6000
- Classification name
- Whole Exome Sequencing Constituent Device
- Medical specialty
- Medical Genetics
- Review panel
- Medical Genetics
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Gloria Lee
- Address
- 96 Colbeck St. Toronto CA M6S1 V2 M6S1 V2
Source Documents
510(k) summary PDF not indicated by FDA