510(k) K992252

LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965 by Chemicon Intl., Inc. — Product Code LYF

K992252 is an FDA 510(k) premarket notification submitted by Chemicon Intl., Inc. for the device "LIGHT DIAGNOSTICS PNEUMOCYSTIS CARINII DFA, MODEL 31965". The FDA issued a decision of Substantially Equivalent on August 10, 1999. The device falls under product code LYF (Pneumocystis Carinii), a Class II device regulated under 21 CFR 866.3780. Chemicon Intl., Inc. has at least 7 other 510(k) clearances on record.