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) (3) Calibrator For Cell Indices (KRX) (1)

Premarket Exempt

Clear

MINOCAL - 00856605006103 Catalog Number : 5300100152

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 CRP - 00856605006110 Catalog Number : 5302042205

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 CRP - 00856605006127 Catalog Number : 5302042206

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 CRP - 00856605006134 Catalog Number : 5302042207

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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