Cleared Traditional

MULTIGENT GENTAMICIN

K060709 · Seradyn, Inc. · Toxicology
Jun 2006
Decision
91d
Days
Class 2
Risk

About This 510(k) Submission

K060709 is an FDA 510(k) clearance for the MULTIGENT GENTAMICIN, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 15, 2006, 91 days after receiving the submission on March 16, 2006. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K060709 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 2006
Decision Date June 15, 2006
Days to Decision 91 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LCD — Enzyme Immunoassay, Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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