RANDOX INORGANIC PHOSPHOROUS— 510(k) K974605

Name: FDA 510(k) clearance K974605
Creator: U.S. Food and Drug Administration
Published: 1998-01-09

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K974605 for RANDOX INORGANIC PHOSPHOROUS, Substantially Equivalent on 1998-01-09. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CEO
Device class: Class 1
Regulation: 21 CFR 862.1580
Advisory panel: Clinical Chemistry
Date received: 1997-12-10
Decision date: 1998-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

Download summary PDF View on FDA.gov ↗

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