Cleared Traditional

CRP DIAGNOSTIC ASSAY

K050836 · Sentinel Ch. Srl · Chemistry
Aug 2005
Decision
129d
Days
Class 2
Risk

About This 510(k) Submission

K050836 is an FDA 510(k) clearance for the CRP DIAGNOSTIC ASSAY, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Sentinel Ch. Srl (Rome, IT). The FDA issued a Cleared decision on August 8, 2005, 129 days after receiving the submission on April 1, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K050836 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2005
Decision Date August 08, 2005
Days to Decision 129 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DCK — C-reactive Protein, Antigen, Antiserum, And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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