Cleared Traditional

K-ASSAY TRANSFERRIN

K993537 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K993537 is an FDA 510(k) clearance for the K-ASSAY TRANSFERRIN, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 30, 1999, 42 days after receiving the submission on October 19, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K993537 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 1999
Decision Date November 30, 1999
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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