Ihealth Labs, Inc.

Ihealth Labs, Inc. — FDA 510(k) Submissions

Ihealth Labs, Inc. has submitted 4 FDA 510(k) premarket notifications since 2024, of which 4 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Multi-analyte Respiratory Virus Antigen Detection Test, Over-the-counter Covid-19 Antigen Test, Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) . Use the specialty filter in the sidebar to narrow results.