RANDOX CARBAMAZEPINE— 510(k) K011648

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K011648 for RANDOX CARBAMAZEPINE, Substantially Equivalent on 2002-01-15. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 2001-05-29
Decision date: 2002-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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