Cleared Traditional

ROCHE ONLINE GENTAMICIN

K020704 · Roche Diagnostics Corp. · Toxicology
Jul 2002
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K020704 is an FDA 510(k) clearance for the ROCHE ONLINE GENTAMICIN, a Enzyme Immunoassay, Gentamicin (Class II — Special Controls, product code LCD), submitted by Roche Diagnostics Corp. (Indianapolos, US). The FDA issued a Cleared decision on July 12, 2002, 130 days after receiving the submission on March 4, 2002. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3450.

Submission Details

510(k) Number K020704 FDA.gov
FDA Decision Cleared SESE
Date Received March 04, 2002
Decision Date July 12, 2002
Days to Decision 130 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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