DART PHENYTOIN— 510(k) K880294

Substantially Equivalent

Coulter Electronics, Inc.

FDA 510(k) clearance K880294 for DART PHENYTOIN, Substantially Equivalent on 1988-05-27. Applicant: Coulter Electronics, Inc..

Clearance details

Applicant: Coulter Electronics, Inc.
Product code: Code LFO
Advisory panel: Clinical Toxicology
Date received: 1988-01-25
Decision date: 1988-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hialeah, FL, US

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