TRIGLYCERIDES GPO-PAP— 510(k) K923508

Name: FDA 510(k) clearance K923508
Creator: U.S. Food and Drug Administration
Published: 1993-07-28

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K923508 for TRIGLYCERIDES GPO-PAP, Substantially Equivalent on 1993-07-28. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1992-07-15
Decision date: 1993-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Antrim, N. Ireland, IR

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDT

view all

K150819 — Triglycerides2015-08-06
K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT2013-11-22
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES2013-05-31
K113830 — VANTERA CLINICAL ANALYZER2012-08-30
K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL2011-05-19

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.