FPR CARBAMAZEPINE KIT— 510(k) K894519

Name: FDA 510(k) clearance K894519
Creator: U.S. Food and Drug Administration
Published: 1989-08-28

Substantially Equivalent

Colony Laboratories, Inc.

FDA 510(k) clearance K894519 for FPR CARBAMAZEPINE KIT, Substantially Equivalent on 1989-08-28. Applicant: Colony Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Colony Laboratories, Inc.
Product code: Code KLT
Device class: Class 2
Regulation: 21 CFR 862.3645
Advisory panel: Clinical Toxicology
Date received: 1989-07-20
Decision date: 1989-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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