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 |