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In vitro diagnostic medical devices
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IVD instruments
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Chemistry / immunochemistry instruments
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Blood gas analysis / electrolyte instruments
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Limited panel analysers for blood gas analysis / electrolytes
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Ion selective electrolyte analysers
Ion selective electrolyte analysers
W0201040201
72 devices
Devices
Ion-Selective Analyzer
Sensa Core Medical Instrumentation Pvt.Ltd.
·
,
IN
Class A
CE/IVDR
Spotchem El (Se-1520)
ARKRAY Factory, Inc.
·
,
JP
IVD General
CE/IVDD
Spotchem El (Se-1520)
ARKRAY Factory, Inc.
·
,
JP
IVD General
CE/IVDD
Blue & White
JS Medicina Electrónica SRL
·
,
AR
Class A
CE/IVDR
Ion-Selective Analyzer
Sensa Core Medical Instrumentation Pvt.Ltd.
·
,
IN
Class A
CE/IVDR
Diestro
JS Medicina Electrónica SRL
·
,
AR
Class A
CE/IVDR
Ion-Selective Analyzer
Sensa Core Medical Instrumentation Pvt.Ltd.
·
,
IN
Class A
CE/IVDR
Diestro
JS Medicina Electrónica SRL
·
,
AR
Class A
CE/IVDR
Ion Selective Analyzer
DIAMOND DIAGNOSTICS Inc
·
,
US
Class A
CE/IVDR
Z-ELITE Pro+
ZOVEC diagnostics GmbH
·
,
DE
IVD General
CE/IVDD
ISE Analyzer
DIAMOND DIAGNOSTICS Inc
·
,
US
Class A
CE/IVDR
HumaLyte Plus 5
Human Gesellschaft für Biochemica und Diagnostica mbH
·
,
DE
Class A
CE/IVDR
Electrolyte Analyzer
Meizhou Cornley Hi-Tech Co., Ltd.
·
,
CN
Class A
CE/IVDR
ProLyte Electrolyte Analyzer
DIAMOND DIAGNOSTICS Inc
·
,
US
Class A
FDA 510(k)
K102959
Active
Cleared 14 Jan 2011
FDA 510(k)
K121140
Active
Cleared 22 Aug 2012
+3
authorizations
Z-ELITE Li
ZOVEC diagnostics GmbH
·
,
DE
IVD General
CE/IVDD
Diestro
JS Medicina Electrónica SRL
·
,
AR
Class A
CE/IVDR
Ex-D
Jokoh Co., Ltd.
·
,
JP
Class A
CE/IVDR
Ion-Selective Analyzer
Sensa Core Medical Instrumentation Pvt.Ltd.
·
,
IN
Class A
CE/IVDR
Diestro
JS Medicina Electrónica SRL
·
,
AR
Class A
CE/IVDR
Z-ELITE Electrolyte Analyzer with Na/K/Cl analytes
ZOVEC diagnostics GmbH
·
,
DE
IVD General
CE/IVDD
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