The following data is part of a premarket notification filed by Beckman Coulter with the FDA for Cytomics Fc 500 Series (mpl Or Mcl) Flow Cytometer.
| Device ID | K182886 |
| 510k Number | K182886 |
| Device Name: | Cytomics FC 500 Series (MPL Or MCL) Flow Cytometer |
| Classification | Counter, Differential Cell |
| Applicant | Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Contact | Samy Puccio |
| Correspondent | Samy Puccio Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 -2500 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2019-09-06 |
| Summary: | summary |