Automated Blood Coagulation Analyzer CA-600 series

GUDID 04987562425716

Automated Blood Coagulation Analyzer CA-660

SYSMEX CORPORATION

Coagulation analyser IVD, laboratory, automated Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory Coagulation analyser IVD, laboratory

• Primary Device ID: 04987562425716
• NIH Device Record Key: e09975ba-1d4f-42c1-bce5-c41182d08605
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Automated Blood Coagulation Analyzer CA-600 series
• Version Model Number: CK978289
• Company DUNS: 690664461
• Company Name: SYSMEX CORPORATION
• 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

Customer Support Contacts

• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com
• Phone: +1(888)879-7639
• Email: crc@sysmex.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987562425716 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031377

FDA Product Code

• GKP: INSTRUMENT, COAGULATION, AUTOMATED

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: 2018-09-18
• Device Publish Date: 2016-08-05

On-Brand Devices [Automated Blood Coagulation Analyzer CA-600 series]

• 04987562425716: Automated Blood Coagulation Analyzer CA-660
• 04987562425686: Automated Blood Coagulation Analyzer CA-620