Cleared Traditional

CEDIA(R) TOBRAMYCIN ASSAY

K912143 · Microgenics Corp. · Toxicology
Jul 1991
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K912143 is an FDA 510(k) clearance for the CEDIA(R) TOBRAMYCIN ASSAY, a Fluorescence Polarization Immunoassay, Tobramycin (Class II — Special Controls, product code LFW), submitted by Microgenics Corp. (Concord, US). The FDA issued a Cleared decision on July 26, 1991, 72 days after receiving the submission on May 15, 1991. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K912143 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1991
Decision Date July 26, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code LFW — Fluorescence Polarization Immunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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