VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668

Ferrozine (colorimetric) Iron Binding Capacity

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Chemistry Products Tibc Kit, Model 886 7541; Calibrator Kit 4, Model 120 4668.

Pre-market Notification Details

• Device ID: K061464
• 510k Number: K061464
• Device Name: VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668
• Classification: Ferrozine (colorimetric) Iron Binding Capacity
• Applicant: Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Contact: Darlene J Phillips
• Correspondent: Darlene J Phillips; Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DR. Rochester, NY 14626 -5101
• Product Code: JMO
• CFR Regulation Number: 862.1415 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-05-25
• Decision Date: 2006-06-15
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750008537	K061464	000