Cleared Traditional

RANDOX AMMONIA

K030873 · Randox Laboratories, Ltd. · Chemistry
May 2003
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K030873 is an FDA 510(k) clearance for the RANDOX AMMONIA, a Enzymatic Method, Ammonia (Class I — General Controls, product code JIF), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on May 12, 2003, 53 days after receiving the submission on March 20, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K030873 FDA.gov
FDA Decision Cleared SESE
Date Received March 20, 2003
Decision Date May 12, 2003
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JIF — Enzymatic Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065

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