Total Bilirubin— 510(k) K152344

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K152344 for Total Bilirubin, Substantially Equivalent on 2016-01-28. Applicant: Randox Laboratories Limited. Device class: 2.

Clearance details

Applicant: Randox Laboratories Limited
Product code: Code JFM
Device class: Class 2
Regulation: 21 CFR 862.1110
Advisory panel: Clinical Chemistry
Date received: 2015-08-19
Decision date: 2016-01-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, County Antrim, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JFM

K170065 — ADVIA® Chemistry Total Bilirubin_2 (TBIL_2)2017-03-09
K152343 — Direct Bilirubin2016-02-16
K063845 — ADVIA CHEMISTRY TOTAL BILIRUBIN_22007-12-07
K053131 — WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-231912005-12-30
K053132 — WAKO DIRECT BILIRUBIN V, MODELS 996-23591, 412-22901, 992-23691, 998-237912005-12-30

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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
K162275 — Randox RX Daytona Plus Alkaline Phosphatase (ALP)2017-04-21
K161691 — Direct LDL Cholesterol (LDL)2017-03-20

Recalls naming K152344

K-number listed on FDA's recall record

Z-0501-2024 — RANDOX Total Bilirubin.Class II·Ongoing·Randox Laboratories Ltd.·20231011

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152344.

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