Cleared Traditional

K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET

K014293 · Kamiya Biomedical Co. · Immunology
Feb 2002
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K014293 is an FDA 510(k) clearance for the K-ASSAY FERRITIN, K-ASSAY FERRITIN CALIBRATOR SET, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on February 19, 2002, 53 days after receiving the submission on December 28, 2001. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K014293 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2001
Decision Date February 19, 2002
Days to Decision 53 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

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