C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS— 510(k) K053603

Name: FDA 510(k) clearance K053603
Creator: U.S. Food and Drug Administration
Published: 2006-02-09

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K053603 for C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR COBAS INTEGRA INSTRUMENTS, Substantially Equivalent on 2006-02-09. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code NQD
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2005-12-23
Decision date: 2006-02-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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