ROCHE ONLINE GENTAMICIN— 510(k) K020704

Name: FDA 510(k) clearance K020704
Creator: U.S. Food and Drug Administration
Published: 2002-07-12

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K020704 for ROCHE ONLINE GENTAMICIN, Substantially Equivalent on 2002-07-12. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2002-03-04
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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