Cleared Traditional

GENTAMICIN FPIA REAGENT SET AND CALIBRATORS

K943550 · Sigma Diagnostics, Inc. · Toxicology
Nov 1994
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K943550 is an FDA 510(k) clearance for the GENTAMICIN FPIA REAGENT SET AND CALIBRATORS, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Sigma Diagnostics, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 17, 1994, 119 days after receiving the submission on July 21, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K943550 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 1994
Decision Date November 17, 1994
Days to Decision 119 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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