Cleared Traditional

TOXOPLASMA GONDII ANTIBODY IGG

K822605 · Immulok, Inc. · Microbiology
Oct 1982
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K822605 is an FDA 510(k) clearance for the TOXOPLASMA GONDII ANTIBODY IGG, a Antisera, If, Toxoplasma Gondii (Class II — Special Controls, product code LJK), submitted by Immulok, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 27, 1982, 61 days after receiving the submission on August 27, 1982. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K822605 FDA.gov
FDA Decision Cleared SESE
Date Received August 27, 1982
Decision Date October 27, 1982
Days to Decision 61 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LJK — Antisera, If, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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