Randox RX Daytona Plus Alkaline Phosphatase (ALP)— 510(k) K162275

Name: FDA 510(k) clearance K162275
Creator: U.S. Food and Drug Administration
Published: 2017-04-21

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K162275 for Randox RX Daytona Plus Alkaline Phosphatase (ALP), Substantially Equivalent on 2017-04-21. Applicant: Randox Laboratories Limited. Device class: 2.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2016-08-12
Decision date: 2017-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJE

view all

K251074 — Tru Liver Health Test Panel2025-12-19
K240468 — Alkaline Phosphatase2024-10-16
K223317 — Alkaline Phosphatase22023-07-21
K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin2019-08-30
K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer2018-01-25

More clearances from Randox Laboratories Limited

view all

K250741 — Evidence MultiSTAT DOA Urine MultiPlex2026-01-23
K220451 — Evidence MultiSTAT DOA Urine MultiPlex, Evidence MultiSTAT2023-10-05
K221550 — Evidence MultiSTAT DOA Urine MultiPlex2023-10-05
K161691 — Direct LDL Cholesterol (LDL)2017-03-20
K152343 — Direct Bilirubin2016-02-16

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