510(k) DEN190035
DEN190035 is an FDA 510(k) premarket notification submitted by Helix Opco, LLC for the device "Helix Laboratory Platform". The FDA issued a decision of De Novo Granted on December 23, 2020. The device falls under product code QNC (Whole Exome Sequencing Constituent Device), a Class II device regulated under 21 CFR 866.6000. Helix Opco, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- December 23, 2020
- Date Received
- August 2, 2019
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Exome Sequencing Constituent Device
- Device Class
- Class II
- Regulation Number
- 866.6000
- Review Panel
- PA
- Submission Type
A whole exome sequencing constituent device is for germline whole exome sequencing of genomic deoxyribonucleic acid (DNA) isolated from human specimens. The DNA sequence generated by this device is intended as input for clinical germline DNA assays that have FDA marketing authorization and are intended for use with this device.