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510(k) DEN190035

Helix Laboratory Platform by Helix Opco, LLC — Product Code QNC

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.

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