Cleared Traditional

IGG

K983221 · Abbott Laboratories · Immunology
Nov 1998
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K983221 is an FDA 510(k) clearance for the IGG, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on November 4, 1998, 51 days after receiving the submission on September 14, 1998. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K983221 FDA.gov
FDA Decision Cleared SESE
Date Received September 14, 1998
Decision Date November 04, 1998
Days to Decision 51 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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