Cleared Traditional

C-REACTIVE PROTEIN (LATEX)

K083444 · Roche Diagnostics Corp. · Immunology
Mar 2009
Decision
117d
Days
Class 2
Risk

About This 510(k) Submission

K083444 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN (LATEX), a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by Roche Diagnostics Corp. (Indianaoplis, US). The FDA issued a Cleared decision on March 18, 2009, 117 days after receiving the submission on November 21, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K083444 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2008
Decision Date March 18, 2009
Days to Decision 117 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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