C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS

Cardiac C-reactive Protein, Antigen, Antiserum, And Control

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for C-reactive Protein (latex) High Sensitive Test System For Cobas Integra Instruments.

Pre-market Notification Details

• Device ID: K053603
• 510k Number: K053603
• Device Name: C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS
• Classification: Cardiac C-reactive Protein, Antigen, Antiserum, And Control
• Applicant: ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250
• Contact: Theresa M Ambrose
• Correspondent: Theresa M Ambrose; ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis, IN 46250
• Product Code: NQD
• CFR Regulation Number: 866.5270 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-12-23
• Decision Date: 2006-02-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613336121207	K053603	000
04015630928774	K053603	000
04015630921508	K053603	000