FPR PHENYTOIN KIT— 510(k) K894527

Substantially Equivalent

Colony Laboratories, Inc.

FDA 510(k) clearance K894527 for FPR PHENYTOIN KIT, Substantially Equivalent on 1989-09-25. Applicant: Colony Laboratories, Inc..

Clearance details

Applicant: Colony Laboratories, Inc.
Product code: Code DLP
Advisory panel: Clinical Toxicology
Date received: 1989-07-20
Decision date: 1989-09-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

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