510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN190035Unknown

Helix Laboratory Platform

Helix Opco, LLC, Toronto, CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN190035 is the FDA 510(k) clearance record for Helix Laboratory Platform, a class II device, cleared for Helix Opco, LLC on under FDA product code QNC (Whole Exome Sequencing Constituent Device). FDA's definition for product code QNC reads: "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...". FDA records list 2 510(k) clearances for Helix Opco, LLC. As of , FDA records show no recalls naming DEN190035.

Clearance record

Decision date
Received
(509 days to decision)
Product code
QNC Whole Exome Sequencing Constituent Device
Regulation
21 CFR 866.6000
Device class
Class II
Review panel
Medical Genetics
Applicant
Helix Opco, LLC 96 Colbeck St., Toronto, CA
Third party review
No

Clearances, product code QNC

Trailing 12 months

FDA records hold no clearances under product code QNC in the trailing twelve months.

FDA records show no clearances under product code QNC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code QNC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260