510(k) K890768

PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT by Genetic Systems Corp. — Product Code LYF

K890768 is an FDA 510(k) premarket notification submitted by Genetic Systems Corp. for the device "PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KIT". The FDA issued a decision of Substantially Equivalent on March 21, 1989. The device falls under product code LYF (Pneumocystis Carinii), a Class II device regulated under 21 CFR 866.3780. Genetic Systems Corp. has at least 10 other 510(k) clearances on record.