RANDOX GENTAMICIN— 510(k) K012978

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K012978 for RANDOX GENTAMICIN, Substantially Equivalent on 2001-09-18. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2001-07-06
Decision date: 2001-09-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.