RANDOX C-REACTIVE PROTEIN CALIBRATOR— 510(k) K022682

Name: FDA 510(k) clearance K022682
Creator: U.S. Food and Drug Administration
Published: 2002-11-05

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K022682 for RANDOX C-REACTIVE PROTEIN CALIBRATOR, Substantially Equivalent on 2002-11-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2002-08-12
Decision date: 2002-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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