FUJIFILM WAKO PURE CHEMICAL CORPORATION

Address:2613-2 Oaza Ogohara,Komono-Cho Mie,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

Titrimetric, Fatty Acids (JLH) (4)

Premarket Exempt

No Yes

Clear

HR Series NEFA-HR(2) Color Reagent A - 14987481164601 Catalog Number : 999-34691

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : Yes

Product Code : JLH

Prescription Use : Yes

Device Count : 4

HR Series NEFA-HR(2) Solvent A - 14987481164618 Catalog Number : 995-34791

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : Yes

Product Code : JLH

Prescription Use : Yes

Device Count : 4

HR Series NEFA-HR(2) Color Reagent B - 14987481164625 Catalog Number : 991-34891

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : Yes

Product Code : JLH

Prescription Use : Yes

Device Count : 4

HR Series NEFA-HR(2) Solvent B - 14987481164632 Catalog Number : 993-35191

Device Description : In-Vitro Diagnostic Use

Device Class : 1

Duns Number: 690598875

Premarket Exempt : Yes

Product Code : JLH

Prescription Use : Yes

Device Count : 4

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