510(k) K150815
K150815 is an FDA 510(k) premarket notification submitted by Becton, Dickinson and Company for the device "BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit". The FDA issued a decision of Substantially Equivalent on December 17, 2015. The device falls under product code PMG (Automated Multicolor Fluorescent Imaging Cytometric Analysis System), a Class II device regulated under 21 CFR 864.5220. Becton, Dickinson and Company has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 17, 2015
- Date Received
- March 27, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Automated Multicolor Fluorescent Imaging Cytometric Analysis System
- Device Class
- Class II
- Regulation Number
- 864.5220
- Review Panel
- HE
- Submission Type
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.