Cleared Traditional

TOXO IPA KIT IAN INDIRECT FLUORESCENT

K832069 · Bionetic Laboratory Products · Immunology
Sep 1983
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K832069 is an FDA 510(k) clearance for the TOXO IPA KIT IAN INDIRECT FLUORESCENT, a Antisera, If, Toxoplasma Gondii (Class II — Special Controls, product code LJK), submitted by Bionetic Laboratory Products (Mchenry, US). The FDA issued a Cleared decision on September 26, 1983, 91 days after receiving the submission on June 27, 1983. This device falls under the Immunology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K832069 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 1983
Decision Date September 26, 1983
Days to Decision 91 days
Submission Type Traditional
Review Panel Immunology (IM)
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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