APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC KIT— 510(k) K950382

Name: FDA 510(k) clearance K950382
Creator: U.S. Food and Drug Administration
Published: 1995-09-15

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K950382 for APOLIPOPROTEIN B IMMUNOTURBIDIEMETRIC 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 ↗

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K952466 — OLYMPUS APOLIPOPROTEIN B IMMUNOTURBIDIMETRIC REAGENT1995-06-05
K932603 — APOLIPOPROTIEN B (APO B)1994-06-02

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