510(k) K843534

ORAL THC-CANNABINOIDS DIRECT RIA KIT by Immunalysis Corporation — Product Code LAT

K843534 is an FDA 510(k) premarket notification submitted by Immunalysis Corporation for the device "ORAL THC-CANNABINOIDS DIRECT RIA KIT". The FDA issued a decision of Substantially Equivalent on October 30, 1984. The device falls under product code LAT (Radioimmunoassay, Cannabinoid(S)), a Class II device regulated under 21 CFR 862.3870. Immunalysis Corporation has at least 10 other 510(k) clearances on record.