Cleared Traditional

OPUS GENTAMICIN

K905721 · Pb Diagnostic Systems, Inc. · Toxicology
Feb 1991
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K905721 is an FDA 510(k) clearance for the OPUS GENTAMICIN, a Fluorescent Immunoassay Gentamicin (Class II — Special Controls, product code LCQ), submitted by Pb Diagnostic Systems, Inc. (Westwood, US). The FDA issued a Cleared decision on February 21, 1991, 62 days after receiving the submission on December 21, 1990. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K905721 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1990
Decision Date February 21, 1991
Days to Decision 62 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code LCQ — Fluorescent Immunoassay Gentamicin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3450

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