Cleared Traditional

K-ASSAY HS-CRP CONTROLS

K011079 · Kamiya Biomedical Co. · Immunology
May 2001
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K011079 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 May 16, 2001, 37 days after receiving the submission on April 9, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K011079 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 2001
Decision Date May 16, 2001
Days to Decision 37 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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