510(k) K901027

AUTOMATED EIA MICROPLATE READER MODELS EL312/312I by Bio-Tek Instruments, Inc. — Product Code JJQ

K901027 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "AUTOMATED EIA MICROPLATE READER MODELS EL312/312I". The FDA issued a decision of Substantially Equivalent on April 9, 1990. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Bio-Tek Instruments, Inc. has at least 10 other 510(k) clearances on record.