510(k) K821965

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

K821965 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 July 20, 1982. 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.