Cleared Traditional

PLATELIA TOXO IGM KIT

K894948 · Kallestad Diag, A Div. of Erbamont, Inc. · Microbiology
Mar 1990
Decision
224d
Days
Class 2
Risk

About This 510(k) Submission

K894948 is an FDA 510(k) clearance for the PLATELIA TOXO IGM KIT, a Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (Class II — Special Controls, product code LGD), submitted by Kallestad Diag, A Div. of Erbamont, Inc. (Chaska, US). The FDA issued a Cleared decision on March 15, 1990, 224 days after receiving the submission on August 3, 1989. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3780.

Submission Details

510(k) Number K894948 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 1989
Decision Date March 15, 1990
Days to Decision 224 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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