RANDOX THERAPEUTIC DRUG CALIBRATOR— 510(k) K012318

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K012318 for RANDOX THERAPEUTIC DRUG CALIBRATOR, Substantially Equivalent on 2001-09-12. Applicant: Randox Laboratories, Ltd..

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DKB
Advisory panel: Clinical Toxicology
Date received: 2001-07-23
Decision date: 2001-09-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, Co. Antrim, GB

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