The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System.
Device ID | K162414 |
510k Number | K162414 |
Device Name: | UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System |
Classification | Counter, Differential Cell |
Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 |
Contact | Nancy Nadler |
Correspondent | Nancy Nadler BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 |
Product Code | GKZ |
CFR Regulation Number | 864.5220 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-08-29 |
Decision Date | 2016-11-29 |
Summary: | summary |