meddevicedb.com FDA Device Reference

Helix Laboratory Platform

DEN190035 Class II Direct
Decision Date
2020-12-23
Sponsor / Applicant
Helix Opco, LLC

Technical Specification

510(k) Submission ID DEN190035
Product Code QNC
Medical Specialty / Panel Medical Genetics
Regulation Citation 21 CFR 866.6000
Decision Date 2020-12-23
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

Helix Laboratory Platform received FDA 510(k) clearance under submission number DEN190035, sponsored by Helix Opco, LLC. The device was reviewed via the Direct premarket notification pathway and assigned to the Medical Genetics review panel. The statutory decision date of record is 2020-12-23.

Classification & Regulation

This clearance is catalogued under FDA product code QNC and 21 CFR 866.6000, within the Medical Genetics review panel as a Class II device.