|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
|
xw-100 automated hematology analyzer, xw qc check
|
SYSMEX AMERICA, INC.
|
K143577 |
10/12/2015
|
xw-100 automated hematology analyzer for clia waived use
|
Sysmex America, Inc.
|
K172604 |
11/06/2017
|
sysmex xw-100 automated hematology analyzer
|
Sysmex America, INC.
|
K210346 |
11/08/2022
|
sysmex xt-series ig parameter,sysmex xt-series ret-he parameter
|
SYSMEX AMERICA, INC.
|
K081890 |
10/10/2008
|
sysmex xq-series (xq-320) automated hematology analyzer
|
Sysmex America, Inc.
|
K230887 |
12/21/2023
|
sysmex xn-series
|
SYSMEX AMERICA, INC.
|
K112605 |
10/19/2012
|
sysmex xn-l automated hematology analyzer
|
SYSMEX AMERICA, INC.
|
K160538 |
12/22/2016
|
sysmex xn-l automated hematology analyzer
|
Sysmex America, Inc.
|
K182389 |
01/25/2019
|
sysmex xn series
|
SYSMEX AMERICA, INC.
|
K141681 |
12/05/2014
|
sysmex xe-5000
|
SYSMEX AMERICA, INC.
|
K071967 |
11/20/2007
|
|