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

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..

Clearance details

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

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