Cleared Traditional

FPR TOBRAMYCIN KIT

K894531 · Colony Laboratories, Inc. · Toxicology
Sep 1989
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K894531 is an FDA 510(k) clearance for the FPR TOBRAMYCIN KIT, a Fluorescence Polarization Immunoassay, Tobramycin (Class II — Special Controls, product code LFW), submitted by Colony Laboratories, Inc. (Washington, US). The FDA issued a Cleared decision on September 1, 1989, 43 days after receiving the submission on July 20, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K894531 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date September 01, 1989
Days to Decision 43 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

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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