RANDOX ALBUMIN— 510(k) K000483

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K000483 for RANDOX ALBUMIN, Substantially Equivalent on 2000-03-31. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CJW
Device class: Class 2
Regulation: 21 CFR 862.1035
Advisory panel: Clinical Chemistry
Date received: 2000-02-14
Decision date: 2000-03-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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