ACS PHENYTOIN ASSAY— 510(k) K955873

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K955873 for ACS PHENYTOIN ASSAY, Substantially Equivalent on 1996-03-11. Applicant: Ciba Corning Diagnostics Corp..

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code LGR
Advisory panel: Clinical Toxicology
Date received: 1995-12-26
Decision date: 1996-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Medfield, MA, US

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