Cleared Traditional

TOXOPLASMA GONDII IGG ELISA

K871905 · Electro-Nucleonics Laboratories, Inc. · Microbiology
Jul 1987
Decision
76d
Days
Class 2
Risk

About This 510(k) Submission

K871905 is an FDA 510(k) clearance for the TOXOPLASMA GONDII IGG ELISA, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Electro-Nucleonics Laboratories, Inc. (Columbia, US). The FDA issued a Cleared decision on July 30, 1987, 76 days after receiving the submission on May 15, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K871905 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1987
Decision Date July 30, 1987
Days to Decision 76 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LGD — Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3780

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