HORIBA INSTRUMENTS INCORPORATED

Address:5449 RESEARCH DRIVE,Canton Twp,MI,48188,US

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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

Mixture, Hematology Quality Control (JPK) (9) Calibrator For Cell Indices (KRX) (1)

Premarket Exempt

Clear

MINOCAL - 00856605006004 Catalog Number : 5300000276

Device Description : Whole Blood Hematology Calibrator

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : KRX

Prescription Use : No

Device Count : 1

MINOTROL 16 - 00856605006011 Catalog Number : 5300000277

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

MINOTROL 16 - 00856605006028 Catalog Number : 5300000278

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

MINOTROL 16 - 00856605006035 Catalog Number : 5300000283

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

MINOTROL RETIC - 00856605006042 Catalog Number : 5300000284

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

MINOTROL RETIC - 00856605006059 Catalog Number : 5300100075

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

DIFFTROL - 00856605006066 Catalog Number : 5300100112

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

DIFFTROL - 00856605006073 Catalog Number : 5300100141

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

DIFFTROL - 00856605006080 Catalog Number : 5300100142

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

DIFFTROL - 00856605006097 Catalog Number : 5300100147

Device Description : Whole Blood Hematology Control

Device Class : 2

Duns Number: 052845583

Premarket Exempt : No

Product Code : JPK

Prescription Use : No

Device Count : 1

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