SYSMEX CORPORATION

Address:1-5-1 WAKINOHAMA-KAIGANDORI,KOBE Hyogo,JP

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Counter, differential cell (GKZ) (6) CALIBRATOR, SURROGATE (JIW) (1) COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) (GKL) (1) COUNTER, URINE PARTICLE (LKM) (1) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (1) SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES (JPA) (1)

Premarket Exempt

No Yes

Clear

CA CAL S - 04987562205936 Catalog Number :

Device Description : CA CAL S 3.0X3 (GCL-100A)

Device Class :

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKP

Prescription Use : Yes

Device Count : 3

Automated Hematology Analyzer pocH-100i - 04987562402021 Catalog Number :

Device Description : pocH-100i (US)

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ, GKL

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XE-2100D - 04987562404087 Catalog Number :

Device Description : Automated Hematology Analyzer XE-2100D

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XS series XS-1000i - 04987562406807 Catalog Number :

Device Description : Sysmex XS-1000i™ Automated Hematology Analyzer

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

UF ll CALIBRATOR - 04987562408535 Catalog Number :

Device Description : UF ll CALIBRATOR

Device Class :

Duns Number: 690664461

Premarket Exempt : No

Product Code : JIW

Prescription Use : Yes

Device Count : 2

Fully Automated Urine Particle Analyzer UF-1000i - 04987562408542 Catalog Number :

Device Description : Sysmex UF-1000i™ Automated Urine Particle Analyzer

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : LKM

Prescription Use : Yes

Device Count : 1

Automated Blood Coagulation Analyzer CS-2100i - 04987562409471 Catalog Number :

Device Description : CS-2100i COMPLETE

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XS series XS-1000iC - 04987562412860 Catalog Number :

Device Description : XS-1000iC Complete

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN series XN-10 - 04987562424214 Catalog Number :

Device Description : XN-10 Complete

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN series XN-20 - 04987562424221 Catalog Number :

Device Description : Automated Hematology Analyzer XN series XN-20

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

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