Cleared Traditional

K-ASSAY IGG

K993281 · Kamiya Biomedical Co. · Immunology
Nov 1999
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K993281 is an FDA 510(k) clearance for the K-ASSAY IGG, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Kamiya Biomedical Co. (Seattle, US). The FDA issued a Cleared decision on November 9, 1999, 40 days after receiving the submission on September 30, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K993281 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1999
Decision Date November 09, 1999
Days to Decision 40 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

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

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