Cleared Traditional

CRP-ADVANCE ASSAY, MODELS 250-20, 250-25

K060139 · Diagnostic Chemicals , Ltd. · Chemistry
Apr 2006
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K060139 is an FDA 510(k) clearance for the CRP-ADVANCE ASSAY, MODELS 250-20, 250-25, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Diagnostic Chemicals , Ltd. (Charlottetown, P.E., CA). The FDA issued a Cleared decision on April 28, 2006, 99 days after receiving the submission on January 19, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K060139 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2006
Decision Date April 28, 2006
Days to Decision 99 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

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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