Cleared Traditional

ANTIHUMAN IGG GLOBULIN FITC LABELED

K821018 · Microbiological Research Corp. · Immunology
Apr 1982
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K821018 is an FDA 510(k) clearance for the ANTIHUMAN IGG GLOBULIN FITC LABELED, a Igg, Antigen, Antiserum, Control (Class II — Special Controls, product code DEW), submitted by Microbiological Research Corp. (Mchenry, US). The FDA issued a Cleared decision on April 29, 1982, 17 days after receiving the submission on April 12, 1982. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K821018 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1982
Decision Date April 29, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

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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