510(k) K792693

CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX by Meridian Diagnostics, Inc. — Product Code GMD

K792693 is an FDA 510(k) premarket notification submitted by Meridian Diagnostics, Inc. for the device "CRYPTOCOCCUS NEOFORMANS ANTISERUM, LATEX". The FDA issued a decision of Substantially Equivalent on January 21, 1980. The device falls under product code GMD (Antisera, Latex Agglutination, Cryptococcus Neoformans), a Class II device regulated under 21 CFR 866.3165. Meridian Diagnostics, Inc. has at least 10 other 510(k) clearances on record.