510(k) K950104

ELX800 AND EL800 AUTOMATED MICROPLATE READERS by Bio-Tek Instruments, Inc. — Product Code JJQ

K950104 is an FDA 510(k) premarket notification submitted by Bio-Tek Instruments, Inc. for the device "ELX800 AND EL800 AUTOMATED MICROPLATE READERS". The FDA issued a decision of Substantially Equivalent on March 21, 1995. 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.