← Back to Clearance Database
510(k) · DEN190035

Helix Laboratory Platform

Helix Opco, LLC
Pulmonary Class II MG
Clearance Date
December 23, 2020
Product Code
QNC
Device Class
Class II
Review Track
MG
PCCP
No
Submission Type
510(k)
Track every AI device clearance like this one
AIFDA Intel monitors 510(k) and De Novo clearances for AI medical devices — alerts, predicate search, competitive intelligence, all in one place.
Start free trial →
Not building an AI/ML device? Predicase searches the full FDA 510(k) database — all 175,000+ clearances, every device type. Try Predicase →