FDA product code PMG: Automated Multicolor Fluorescent Imaging Cytometric Analysis System
PMG is the FDA product code for automated multicolor fluorescent imaging cytometric analysis system. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel. FDA has cleared 1 510(k) submission under PMG. The average 510(k) review took 265 days (median 265).
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.
Classification
| Field | Value |
|---|---|
| Device name | Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
| Device class | Class II |
| Regulation | 21 CFR 864.5220 |
| Review panel | HE — Hematology |
| Medical specialty | Hematology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every PMG clearance
Top PMG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Becton, Dickinson and Company | 1 | 2015-12-17 |
Most recent PMG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K150815 | Becton, Dickinson and Company | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit | 2015-12-17 | 265 |
Recalls for PMG devices
openFDA lists no recalls for product code PMG.
Frequently asked questions
What is FDA product code PMG?
PMG is the FDA product code for automated multicolor fluorescent imaging cytometric analysis system. It is a Class II device, regulated under 21 CFR 864.5220 and reviewed by the Hematology panel.
What device class is PMG?
Class II, regulation 21 CFR 864.5220. Typical premarket route: 510(k).
How long does a 510(k) take for product code PMG?
Across 1 cleared submissions the average was 265 days from receipt to decision (median 265).
Which companies have the most PMG clearances?
Becton, Dickinson and Company (1).
Next steps
- Run an FDA pathway report with predicate devices for product code PMG
- Run a recall and safety report across every PMG manufacturer
- Watch product code PMG for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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