Cleared Traditional

TOXO IGG ELISA TEST (MODIFIED)

K915891 · Gull Laboratories, Inc. · Microbiology
Mar 1992
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K915891 is an FDA 510(k) clearance for the TOXO IGG ELISA TEST (MODIFIED), 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 4, 1992, 71 days after receiving the submission on December 24, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K915891 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1991
Decision Date March 04, 1992
Days to Decision 71 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

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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