SYSMEX CORPORATION

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

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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) (5) SYSTEM, MULTIPURPOSE FOR IN VITRO COAGULATION STUDIES (JPA) (3) INSTRUMENT, COAGULATION, AUTOMATED (GKP) (2) COUNTER, CELL, AUTOMATED (PARTICLE COUNTER) (GKL) (1) Calibrator, surrogate (JIW) (1)

Premarket Exempt

No Yes

Clear

Automated Blood Coagulation Analyzer CS-5100 - 04987562425426 Catalog Number :

Device Description : CS-5100 COMPLETE

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 1

Automated Blood Coagulation Analyzer CA-600 series CA-620 - 04987562425686 Catalog Number :

Device Description : Automated Blood Coagulation Analyzer CA-620

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : JPA, GKP

Prescription Use : Yes

Device Count : 1

Automated Blood Coagulation Analyzer CA-600 series CA-660 - 04987562425716 Catalog Number :

Device Description : Automated Blood Coagulation Analyzer CA-660

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKP

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XP series XP-300 - 04987562429219 Catalog Number :

Device Description : Automated Hematology Analyzer XP-300

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ, GKL

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN series XN-11 - 04987562432615 Catalog Number :

Device Description : XN-11 Complete

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

UF-CALIBRATOR - 04987562433698 Catalog Number :

Device Description : UF-CALIBRATOR

Device Class :

Duns Number: 690664461

Premarket Exempt : Yes

Product Code : JIW

Prescription Use : Yes

Device Count : 2

Automated Blood Coagulation Analyzer CS-2500 - 04987562433735 Catalog Number :

Device Description : CS-2500 COMPLETE

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : JPA

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN-L series XN-330 - 04987562434527 Catalog Number :

Device Description : Automated Hematology Analyzer XN-L series XN-330

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN-L series XN-350 - 04987562434534 Catalog Number :

Device Description : Automated Hematology Analyzer XN-L series XN-350

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

Automated Hematology Analyzer XN-L series XN-430 - 04987562434541 Catalog Number :

Device Description : Automated Hematology Analyzer XN-L series XN-430

Device Class : 2

Duns Number: 690664461

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

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