Automated Multicolor Fluorescent Imaging Cytometric Analysis System
PMG is the FDA product code for Automated Multicolor Fluorescent Imaging Cytometric Analysis System, a class II device type, regulated under 21 CFR 864.5220. FDA's definition for this code reads: "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". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.
Classification record
- Product code
- PMG
- Device name
- Automated Multicolor Fluorescent Imaging Cytometric Analysis System
- 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.
- Regulation
- 21 CFR 864.5220
- Device class
- Class II
- Review panel
- Hematology
- Submission type
- 510(k)
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- No
- Third party review eligible
- Yes
- Ingested clearances
- 1
- Ingested recalls
- 0
Clearances, product code PMG
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 2015 | 1 |
Applicants with the most clearances
Product code PMG| Applicant | Clearances |
|---|---|
| Becton Dickinson & Co | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
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