Cleared Special

K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE

K002558 · Kamiya Biomedical Co. · Immunology
Oct 2000
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K002558 is an FDA 510(k) clearance for the K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE, a C-reactive Protein, Antigen, Antiserum, And Control (Class II — Special Controls, product code DCK), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on October 25, 2000, 72 days after receiving the submission on August 14, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K002558 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2000
Decision Date October 25, 2000
Days to Decision 72 days
Submission Type Special
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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