DeviceClearance

Product code PMG— Hematology

BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit

Classification name
Automated Multicolor Fluorescent Imaging Cytometric Analysis System
Device class
Class 2
Regulation
21 CFR 864.5220
Advisory panel
Hematology
Total cleared
1
First cleared
Most recent

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.”

— U.S. Food and Drug Administration, device classification record for product code PMG under 21 CFR 864.5220, via openFDA

Market context for product code PMG

FDA has cleared 1 device under product code PMG, all in 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code PMG

Recent clearances under product code PMG

Data sourced from openFDA. This site is unofficial and independent of the FDA.