Cleared Traditional

QMS TOBRAMYCIN

K060998 · Seradyn, Inc. · Chemistry
Jul 2006
Decision
101d
Days
Class 2
Risk

About This 510(k) Submission

K060998 is an FDA 510(k) clearance for the QMS TOBRAMYCIN, a Fluorescent Immunoassay, Tobramycin (Class II — Special Controls, product code LCR), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on July 21, 2006, 101 days after receiving the submission on April 11, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3900.

Submission Details

510(k) Number K060998 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2006
Decision Date July 21, 2006
Days to Decision 101 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LCR — Fluorescent Immunoassay, Tobramycin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3900

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