AP 720S™ Semi-Automated Processor 93602

GUDID 00813382010211

AP 720S™ Semi-Automated Processor

HITACHI CHEMICAL DIAGNOSTICS, INC.

Chemiluminescent immunoassay analyser IVD, semi-automated

• Primary Device ID: 00813382010211
• NIH Device Record Key: 991fc047-bbed-42a2-94a9-34b81d51b725
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AP 720S™ Semi-Automated Processor
• Version Model Number: 93602
• Catalog Number: 93602
• Company DUNS: 102113867
• Company Name: HITACHI CHEMICAL DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: true
• 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: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com
• Phone: +1(650)961-5501
• Email: info@hcdiagnostics.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00813382010211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112910

FDA Product Code

• DHB: System, test, radioallergosorbent (rast) immunological

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-08

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