Cleared Traditional

K-ASSAY HS-CRP CONTROLS

K022486 · Kamiya Biomedical Co. · Immunology
Aug 2002
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K022486 is an FDA 510(k) clearance for the K-ASSAY HS-CRP CONTROLS, 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 August 14, 2002, 16 days after receiving the submission on July 29, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K022486 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2002
Decision Date August 14, 2002
Days to Decision 16 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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