VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7

C-reactive Protein, Antigen, Antiserum, And Control

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 Crp Slide And Calibrator Kit 7.

Pre-market Notification Details

• Device ID: K030626
• 510k Number: K030626
• Device Name: VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7
• Classification: C-reactive Protein, Antigen, Antiserum, And Control
• 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: DCK
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-27
• Decision Date: 2003-03-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10758750008827	K030626	000