Cleared Traditional

K-ASSAY IGM

K993323 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K993323 is an FDA 510(k) clearance for the K-ASSAY IGM, a Immunoelectrophoretic, Immunoglobulins, (g, A, M) (Class II — Special Controls, product code CFF), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 30, 1999, 57 days after receiving the submission on October 4, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K993323 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 1999
Decision Date November 30, 1999
Days to Decision 57 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code CFF — Immunoelectrophoretic, Immunoglobulins, (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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