PMGClass II
Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Hematology · 21 CFR 864.5220
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.
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances1All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
1 clearances for this product code