Cleared Traditional

IGM

K983132 · Abbott Laboratories · Immunology
Nov 1998
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K983132 is an FDA 510(k) clearance for the IGM, a Igm, Antigen, Antiserum, Control (Class II — Special Controls, product code DFT), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on November 4, 1998, 57 days after receiving the submission on September 8, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5550.

Submission Details

510(k) Number K983132 FDA.gov
FDA Decision Cleared SESE
Date Received September 08, 1998
Decision Date November 04, 1998
Days to Decision 57 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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