RANDOX BENZODIAZEPINE CLASS ASSAY— 510(k) K050179

Name: FDA 510(k) clearance K050179
Creator: U.S. Food and Drug Administration
Published: 2005-05-17

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K050179 for RANDOX BENZODIAZEPINE CLASS ASSAY, Substantially Equivalent on 2005-05-17. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JXM
Device class: Class 2
Regulation: 21 CFR 862.3170
Advisory panel: Clinical Toxicology
Date received: 2005-01-26
Decision date: 2005-05-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXM

view all

K243498 — Alinity c Benzodiazepines Reagent Kit2024-12-11
K221765 — ONLINE DAT Benzodiazepines II2022-12-23
K190968 — CEDIA Benzodiazepine Assay2019-12-09
K173963 — DRI Benzodiazepine Assay2018-02-21
K163590 — Psychemedics Microplate EIA for Benzodiazepines in Hair2017-09-15

More clearances from Randox Laboratories, Ltd.

view all

DEN240035 — ConcizuTrace ELISA2025-05-22
K230890 — ISE Electrodes2023-09-08
K182042 — Randox Calcium (Ca)2018-10-23
K162200 — Randox RX Daytona Plus Magnesium (MG)2017-04-28
K152085 — Liquid CO2-2 (LCO2-2)2016-02-24

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