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In vitro diagnostic medical devices
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IVD instruments
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Hematology / histology / cytology instruments
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Haematology / cell counting
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Automated 5 part differential hematology analysers
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Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)
W0202010101
299 devices
Automatic Hematology Analyzer
Genegeo Diagnostics (Jiangsu) Co., Ltd.
·
,
China
Class A
CE/IVDR
UniCel® DxH 800 Coulter® Cellular Analysis System
Beckman Coulter, Inc.
·
,
United States
IVD General
CE/IVDD
Automatic Hematology Analyzer
Genegeo Diagnostics (Jiangsu) Co., Ltd.
·
,
China
IVD General
CE/IVDD
LordsMed 5-Part Auto Hematology Analyzer
Lord's Mark Industries Private Limited
·
,
India
Class A
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
Hematology Analyzer
Zybio Inc.
·
,
China
Class B
CE/IVDR
Yumizen H500E CT
Horiba Abx
·
,
France
Class B
CE/IVDR
HTI MicroCC25-Plus
High Technology Inc.
·
,
United States
Class A
CE/IVDR
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
FDA 510(k)
K160429
Active
Cleared 1 Sep 2016
CE/IVDR
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDR
CE/IVDD
Auto Hematology Analyzer
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
·
,
China
Class B
CE/IVDR
TruCell
BioFynder Limited
·
,
United Kingdom
Class A
CE/IVDR
Hematology Analyzer
B&E Bio-Technology Co., Ltd.
·
,
China
Class A
CE/IVDR
Auto Hematology Analyzer
Shenzhen Dymind Biotechnology Co., Ltd.
·
,
China
IVD General
CE/IVDD
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