Cleared Traditional

QMS GENTAMICIN ASSAY

K940376 · Seradyn, Inc. · Toxicology
Jun 1994
Decision
127d
Days
Class 2
Risk

About This 510(k) Submission

K940376 is an FDA 510(k) clearance for the QMS GENTAMICIN ASSAY, 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 2, 1994, 127 days after receiving the submission on January 26, 1994. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K940376 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 1994
Decision Date June 02, 1994
Days to Decision 127 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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