510(k) K895313

MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER by Dynatech Laboratories, Inc. — Product Code JJQ

K895313 is an FDA 510(k) premarket notification submitted by Dynatech Laboratories, Inc. for the device "MICROLITE ML 1000 (MODEL 3) MICROPLATE LUMINOMETER". The FDA issued a decision of Substantially Equivalent on October 17, 1989. The device falls under product code JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use), a Class I device regulated under 21 CFR 862.2300. Dynatech Laboratories, Inc. has at least 10 other 510(k) clearances on record.