Automated Multicolor Fluorescent Imaging Cytometric Analysis System
The Automated Multicolor Fluorescent Imaging Cytometric Analysis System (product code PMG) is a Class 2 hematology device consisting of an automated multicolor fluorescent imaging cytometer and absorbance spectrometer that uses single-use reagent cartridges to identify and enumerate specific hematologic subpopulations and parameters such as hemoglobin, regulated under 864.5220. It requires 510(k) clearance and employs spectrophotometric absorbance and fluorescence measurements. The device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- PMG
- Device Class
- FDA class 2
- Regulation Number
- 864.5220
- Medical Specialty
- Hematology
- Review Panel
- HE
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K150815 | BD FACSPresto System, BD FACSPresto CD4/Hb Cartridge, BD FACSPresto CD4/Hb Cartridge Kit | Dec 17, 2015 | Substantially Equivalent | Becton, Dickinson and Company |
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.