Cleared Traditional

ELISA TOXO IGM

K914852 · Sclavo, Inc. · Microbiology
Jan 1992
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K914852 is an FDA 510(k) clearance for the ELISA TOXO IGM, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Sclavo, Inc. (Wayne, US). The FDA issued a Cleared decision on January 23, 1992, 87 days after receiving the submission on October 28, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K914852 FDA.gov
FDA Decision Cleared SESE
Date Received October 28, 1991
Decision Date January 23, 1992
Days to Decision 87 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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