510(k) K894859

LP 400 MICROPLATE READER by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code JJQ

K894859 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "LP 400 MICROPLATE READER". The FDA issued a decision of Substantially Equivalent on October 31, 1989. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Kallestad Diag, A Div. of Erbamont, Inc. has at least 10 other 510(k) clearances on record.