Cleared Traditional

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD

K945280 · Dupont Medical Products · Immunology
Mar 1995
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K945280 is an FDA 510(k) clearance for the DUPONT DIMENSION C-REACTIVE PROTEIN METHOD, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Dupont Medical Products (Wilmington, US). The FDA issued a Cleared decision on March 9, 1995, 132 days after receiving the submission on October 28, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K945280 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1994
Decision Date March 09, 1995
Days to Decision 132 days
Submission Type Traditional
Review Panel Immunology (IM)
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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