PMG · Class II · 21 CFR 864.5220

FDA Product Code PMG: Automated Multicolor Fluorescent Imaging Cytometric Analysis System

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.

1
Total
1
Cleared
265d
Avg days
2015
Since

FDA 510(k) Cleared Automated Multicolor Fluorescent Imaging Cytometric Analysis System Devices (Product Code PMG)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code PMG - Regulatory Context