The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Unicel Dxh 800 Coulter Cellular Analysis System/ Unicel Dxh Slidemaker Stainer Coulter Cellular Analysis System.
| Device ID | K140911 |
| 510k Number | K140911 |
| Device Name: | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM |
| Classification | Counter, Differential Cell |
| Applicant | BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 |
| Contact | Brent Lemberg |
| Correspondent | Brent Lemberg BECKMAN COULTER, INC. 11800 SW 147TH AVE. Miami, FL 33196 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-09 |
| Decision Date | 2014-09-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590701574 | K140911 | 000 |