RANDOX AMMONIA— 510(k) K030873

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K030873 for RANDOX AMMONIA, Substantially Equivalent on 2003-05-12. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 2003-03-20
Decision date: 2003-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIF

K183517 — Ammonia II2019-02-08
K123677 — DIMENSION VISTA; AMMONIA FLEX REAGENT CARTRIDGE (AMM), CHEMISTRY 3 CALIBRATOR (CHEM 3 CAL)2013-03-07
K123320 — DIMENSION AMMONIA FLEX REAGENT CARTRIDGE2013-02-15
K062316 — DIMENSION VISTA AMMONIA (AMON) FLEX REAGENT CARTRIDGE2006-09-06
K051114 — SENTINEL AMMONIA ULTRA DIAGNOSTIC ASSAY2005-11-25

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Recalls naming K030873

K-number listed on FDA's recall record

Z-2965-2020 — AM1015 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasmaClass II·Terminated·RANDOX LABORATORIES, LTD.·20200730
Z-2966-2020 — AM1054 Randox Ammonia (NH3), Enzymatic UV Method For the quantitative in vitro determination of Ammonia in plasmaClass II·Terminated·RANDOX LABORATORIES, LTD.·20200730

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K030873.

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