RANDOX AMIKACIN— 510(k) K033884

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K033884 for RANDOX AMIKACIN, Substantially Equivalent on 2004-06-09. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code KLQ
Device class: Class 2
Regulation: 21 CFR 862.3035
Advisory panel: Clinical Toxicology
Date received: 2003-12-15
Decision date: 2004-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLQ

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K894517 — FPR AMIKACIN KIT1989-09-28
K852317 — COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR1985-06-25

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