Devices · BECKMAN COULTER, INC.
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
BECKMAN COULTER, INC. is listed for UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM (K120771). The FDA list gives March 22, 2013 as the date of the final decision. The lead panel is Hematology, and the database link on the FDA list is the 510(k) pathway. The primary product code on the FDA list is GKZ. openFDA did not return a classification record for that code in this copy of the data. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K120771
- Date of final decision
- March 22, 2013
- Company on the FDA list
- BECKMAN COULTER, INC.
- Lead panel
- Hematology
- Primary product code
- GKZ
- openFDA device name for the code
- Counter, Differential Cell
- Device class
- 2
- Regulation number
- 864.5220
- openFDA decision description
- Substantially Equivalent
- openFDA decision code
- SESE
- Statement or summary label
- Summary