Cleared Traditional

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT

K962049 · Polymedco, Inc. · Immunology
Dec 1996
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K962049 is an FDA 510(k) clearance for the C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Polymedco, Inc. (Cortlandt Manor, US). The FDA issued a Cleared decision on December 18, 1996, 204 days after receiving the submission on May 28, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K962049 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1996
Decision Date December 18, 1996
Days to Decision 204 days
Submission Type Traditional
Review Panel Immunology (IM)
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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