K150815 is an FDA 510(k) clearance for the BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit. This device is classified as a Automated Multicolor Fluorescent Imaging Cytometric Analysis System (Class II - Special Controls, product code PMG).
Submitted by Becton, Dickinson and Company (San Jose, US). The FDA issued a Cleared decision on December 17, 2015, 265 days after receiving the submission on March 27, 2015.
This device falls under the Immunology FDA review panel. Regulated under 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..
| 510(k) Number | K150815 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2015 |
| Decision Date | December 17, 2015 |
| Days to Decision | 265 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | PMG — Automated Multicolor Fluorescent Imaging Cytometric Analysis System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| 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. |