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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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Rapid test hematology / histology / cytology instruments
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Rapid test hemostasis instruments
Rapid test hemostasis instruments
W02020602
3 devices
Devices
CoaguChek XS System
Roche Diagnostics GmbH
·
,
DE
IVD for self-testing
FDA 510(k)
K060978
Active
Cleared 11 Aug 2006
CE/IVDD
CoaguChek INRange
Roche Diagnostics GmbH
·
,
DE
IVD for self-testing
CE/IVDD
HemoPOC Coagulometer
Helixgen (GUANGZHOU) Co., Ltd.
·
,
CN
IVD for self-testing
CE/IVDD
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