VITROS® Automation Solutions

Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros® Automation Solutions.

Pre-market Notification Details

• Device ID: K160495
• 510k Number: K160495
• Device Name: VITROS® Automation Solutions
• Classification: Enzyme Immunoassay, Non-radiolabeled, Total Thyroxine
• Applicant: Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive MC00881 Rochester, NY 14626
• Contact: Darlene J Phillips
• Correspondent: Darlene J Phillips; Ortho-Clinical Diagnostics, Inc. 100 Indigo Creek Drive MC00881 Rochester, NY 14626
• Product Code: KLI
• Subsequent Product Code: JJE
• Subsequent Product Code: KLT
• Subsequent Product Code: LCD
• CFR Regulation Number: 862.1700 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-02-22
• Decision Date: 2016-10-18
• Summary: summary