Cleared Traditional

QUANTEX IGM

K962201 · Instrumentation Laboratory CO · Immunology
Sep 1996
Decision
110d
Days
Class 2
Risk

About This 510(k) Submission

K962201 is an FDA 510(k) clearance for the QUANTEX IGM, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 25, 1996, 110 days after receiving the submission on June 7, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K962201 FDA.gov
FDA Decision Cleared SESE
Date Received June 07, 1996
Decision Date September 25, 1996
Days to Decision 110 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DFT — Igm, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5550

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