PMG
1 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Automated Multicolor Fluorescent Imaging Cytometric Analysis System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5220
- Medical specialty
- Hematology
- Flags
- Third-party review eligible
- FDA 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.
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| Record | Firm | Date | Builder |
|---|---|---|---|
| BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit (K150815) | Becton, Dickinson and Company | 2015-12-17 | + Add |
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Every clearance here is in the API, with alerts when new ones post.