Cleared Traditional

K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C

K042241 · Kamiya Biomedical Co. · Immunology
Dec 2004
Decision
113d
Days
Class 2
Risk

About This 510(k) Submission

K042241 is an FDA 510(k) clearance for the K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Kamiya Biomedical Co. (Tukwila, US). The FDA issued a Cleared decision on December 10, 2004, 113 days after receiving the submission on August 19, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K042241 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 2004
Decision Date December 10, 2004
Days to Decision 113 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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