Cleared Traditional

RANDOX AMIKACIN

K033884 · Randox Laboratories, Ltd. · Chemistry
Jun 2004
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K033884 is an FDA 510(k) clearance for the RANDOX AMIKACIN, a Radioimmunoassay, Amikacin (Class II — Special Controls, product code KLQ), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on June 9, 2004, 177 days after receiving the submission on December 15, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3035.

Submission Details

510(k) Number K033884 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2003
Decision Date June 09, 2004
Days to Decision 177 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code KLQ — Radioimmunoassay, Amikacin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3035

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