Cleared Traditional

INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET

K872562 · Innotron of Oregon, Inc. · Chemistry
Aug 1987
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K872562 is an FDA 510(k) clearance for the INNOTRON INNOFLUOR TOBRAMYCIN REAGENT SET, a Fluorescence Polarization Immunoassay, Tobramycin (Class II — Special Controls, product code LFW), submitted by Innotron of Oregon, Inc. (Portland, US). The FDA issued a Cleared decision on August 17, 1987, 54 days after receiving the submission on June 24, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K872562 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1987
Decision Date August 17, 1987
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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