AMES TDA TM PHENYTOIN TEST— 510(k) K811025

Name: FDA 510(k) clearance K811025
Creator: U.S. Food and Drug Administration
Published: 1981-04-29

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K811025 for AMES TDA TM PHENYTOIN TEST, Substantially Equivalent on 1981-04-29. Applicant: Miles Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code LES
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1981-04-16
Decision date: 1981-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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