K053603

Substantially Equivalent

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

Applicant: Roche Diagnostics Corp.
Product 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

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.