Cleared Traditional

TOXO IGG ELISA TEST

K962343 · Gull Laboratories, Inc. · Microbiology
Mar 1997
Decision
279d
Days
Class 2
Risk

About This 510(k) Submission

K962343 is an FDA 510(k) clearance for the TOXO IGG ELISA TEST, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Gull Laboratories, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 24, 1997, 279 days after receiving the submission on June 18, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K962343 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 1996
Decision Date March 24, 1997
Days to Decision 279 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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