APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT— 510(k) K950383

Name: FDA 510(k) clearance K950383
Creator: U.S. Food and Drug Administration
Published: 1995-09-15

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K950383 for APOLIPOPROTEIN A-I IMMUNOTURBIDIMETRIC KIT, Substantially Equivalent on 1995-09-15. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JHN
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1995-01-31
Decision date: 1995-09-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JHN

view all

K950382 — APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT1995-09-15
K952615 — WAKO AUTOKIT APO A11995-09-08
K952425 — OLYMPUS APOLIPOPROTEIN A1 IMMUNOTURBIDIMETRIC REAGENT1995-07-05
K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT1995-06-05
K932603 — APOLIPOPROTIEN B (APO B)1994-06-02

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.