DENKA COMPANY LIMITED

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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

Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test (PYP) (5) Multi-Analyte Controls, All Kinds (Assayed) (JJY) (3) Calibrator, Multi-Analyte Mixture (JIX) (2)

Premarket Exempt

No Yes

Clear

s LDL-EX "SEIKEN" - 04987503562760 Catalog Number :

Device Class : 1

Duns Number: 694830238

Premarket Exempt : No

Product Code : PYP

Prescription Use : No

Device Count : 1

s LDL-EX "SEIKEN" - 04987503562791 Catalog Number :

Device Class : 1

Duns Number: 694830238

Premarket Exempt : No

Product Code : PYP

Prescription Use : No

Device Count : 1

s LDL-EX "SEIKEN" - 04987503562807 Catalog Number :

Device Class : 1

Duns Number: 694830238

Premarket Exempt : No

Product Code : PYP

Prescription Use : No

Device Count : 1

small dense LDL Seiken - 04987503562883 Catalog Number : 08834059190

Device Class : 1

Duns Number: 694830238

Premarket Exempt : No

Product Code : PYP

Prescription Use : No

Device Count : 1

small dense LDL Seiken - 04987503562890 Catalog Number : 08834075190

Device Class : 1

Duns Number: 694830238

Premarket Exempt : No

Product Code : PYP

Prescription Use : No

Device Count : 1

Lipid Calibrator S - 04987503563002 Catalog Number :

Device Class : 2

Duns Number: 694830238

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

Lipid Control S-Ⅰ - 04987503563019 Catalog Number :

Device Class : 1

Duns Number: 694830238

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

Lipid Control S-Ⅱ - 04987503563026 Catalog Number :

Device Class : 1

Duns Number: 694830238

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

small dense LDL Calibrator - 04987503563071 Catalog Number : 08834091190

Device Class : 2

Duns Number: 694830238

Premarket Exempt : Yes

Product Code : JIX

Prescription Use : No

Device Count : 1

small dense LDL Control Set - 04987503563088 Catalog Number : 08834105190

Device Class : 1

Duns Number: 694830238

Premarket Exempt : Yes

Product Code : JJY

Prescription Use : No

Device Count : 1

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