small dense LDL Seiken 08834075190

GUDID 04987503562890

DENKA COMPANY LIMITED

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• Primary Device ID: 04987503562890
• NIH Device Record Key: b2fe712c-c95c-420f-8d95-abdc5f74e0e7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: small dense LDL Seiken
• Version Model Number: 08834075190
• Catalog Number: 08834075190
• Company DUNS: 694830238
• Company Name: DENKA COMPANY LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987503562890 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161679

FDA Product Code

• PYP: Low-Density Lipoprotein (Ldl) Cholesterol Sub-Fraction Test

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-21
• Device Publish Date: 2020-10-13

On-Brand Devices [small dense LDL Seiken]

• 04987503562890: 08834075190
• 04987503562883: 08834059190