Cleared Traditional

K-ASSAY LP(A) CONTROLS

K023853 · Kamiya Biomedical Co. · Immunology
Dec 2002
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K023853 is an FDA 510(k) clearance for the K-ASSAY LP(A) CONTROLS, a Lipoprotein, Low-density, Antigen, Antiserum, Control (Class II — Special Controls, product code DFC), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on December 13, 2002, 24 days after receiving the submission on November 19, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5600.

Submission Details

510(k) Number K023853 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 2002
Decision Date December 13, 2002
Days to Decision 24 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DFC — Lipoprotein, Low-density, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5600

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