Direct Bilirubin— 510(k) K152343

Substantially Equivalent

Randox Laboratories Limited

FDA 510(k) clearance K152343 for Direct Bilirubin, Substantially Equivalent on 2016-02-16. 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: 2016-02-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, 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
K152344 — Total Bilirubin2016-01-28
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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Data sourced from openFDA. This site is unofficial and independent of the FDA.