cobas c 513 clinical chemistry analyzer 07649142001

GUDID 04015630946327

Roche Diagnostics GmbH

Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD Multi-modality clinical specimen analysis system IVD

• Primary Device ID: 04015630946327
• NIH Device Record Key: 0cc641de-3d50-4a19-aa0e-7a52aa181b5d
• Commercial Distribution Discontinuation: 2018-07-01
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: cobas c 513 clinical chemistry analyzer
• Version Model Number: 07649142001
• Catalog Number: 07649142001
• Company DUNS: 315028860
• Company Name: Roche Diagnostics GmbH
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04015630946327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160571

FDA Product Code

• JJE: ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2020-10-09
• Device Publish Date: 2017-01-18

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