510(k) K191914

Thermo Scientific Sensititre ARIS HiQ System by Thermo Fisher Scientific — Product Code LRG

K191914 is an FDA 510(k) premarket notification submitted by Thermo Fisher Scientific for the device "Thermo Scientific Sensititre ARIS HiQ System". The FDA issued a decision of Substantially Equivalent on Nov 6, 2019. The device falls under product code LRG (Instrument For Auto Reader & Interpretation Of Overnight Suscept. Systems), a Class II device regulated under 21 CFR 866.1640. Thermo Fisher Scientific has 64 other 510(k) clearances on record.