PMG

Automated Multicolor Fluorescent Imaging Cytometric Analysis System

Product code

PMG

Device name

Automated Multicolor Fluorescent Imaging Cytometric Analysis System

Device class

Class 2

21 CFR

21 CFR 864.5220

Medical specialty

Hematology

Marketing pathway

510(K)

Flag

Third-party review eligible

510(k) clearances (all years, FDA)

1 (all years; only the last 3 years are listed here)

FDA classification definition

An automated multicolor fluorescent imaging cytometer and absorbance spectrometer which utilizes specific single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters (e.g., hemoglobin) using spectrophotometric absorbance measurement and fluorescence measurements.

Definition text from the FDA device classification database (U.S. federal government work, public domain).