510(k) K792282

DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG by California Medical Developments, Inc. — Product Code DKE

K792282 is an FDA 510(k) premarket notification submitted by California Medical Developments, Inc. for the device "DRUGALYZER DTK-1000 KIT PRESUMPTIVE DRUG". The FDA issued a decision of Substantially Equivalent on February 29, 1980. The device falls under product code DKE (Reagents, Test, Tetrahydrocannabinol), a Class II device regulated under 21 CFR 862.3870.