Cleared Traditional

K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

K023828 · Kamiya Biomedical Co. · Immunology
Feb 2003
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K023828 is an FDA 510(k) clearance for the K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR, 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 February 4, 2003, 78 days after receiving the submission on November 18, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K023828 FDA.gov
FDA Decision Cleared SESE
Date Received November 18, 2002
Decision Date February 04, 2003
Days to Decision 78 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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