510(k) K900028

ALLERCOAT MICROPLATE SYSTEM by Kallestad Diag, A Div. of Erbamont, Inc. — Product Code JJQ

K900028 is an FDA 510(k) premarket notification submitted by Kallestad Diag, A Div. of Erbamont, Inc. for the device "ALLERCOAT MICROPLATE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 22, 1990. 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.