RANDOX DIGOXIN ASSAY— 510(k) K102346

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K102346 for RANDOX DIGOXIN ASSAY, Substantially Equivalent on 2011-10-14. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code KXT
Advisory panel: Clinical Toxicology
Date received: 2010-08-19
Decision date: 2011-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

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