PMG — Automated Multicolor Fluorescent Imaging Cytometric Analysis System Class II
FDA product code PMG covers "Automated Multicolor Fluorescent Imaging Cytometric Analysis System", a Class II medical device regulated under 21 CFR 864.5220. Submissions are reviewed by the Hematology panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PMG
- Device Class
- Class II
- Regulation Number
- 864.5220
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K150815 | becton, dickinson and | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartr | December 17, 2015 |