510(k) K243498

Alinity c Benzodiazepines Reagent Kit by Microgenics Corporation — Product Code JXM

K243498 is an FDA 510(k) premarket notification submitted by Microgenics Corporation for the device "Alinity c Benzodiazepines Reagent Kit". The FDA issued a decision of Substantially Equivalent on December 11, 2024. The device falls under product code JXM (Enzyme Immunoassay, Benzodiazepine), a Class II device regulated under 21 CFR 862.3170. Microgenics Corporation has at least 10 other 510(k) clearances on record.