RANDOX PHENOBARBITAL— 510(k) K011303

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K011303 for RANDOX PHENOBARBITAL, Substantially Equivalent on 2001-07-02. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DLZ
Advisory panel: Clinical Toxicology
Date received: 2001-04-30
Decision date: 2001-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, IE

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