INNOFLOUR TOPIRAMATE REAGENT SET— 510(k) K970510

Name: FDA 510(k) clearance K970510
Creator: U.S. Food and Drug Administration
Published: 1997-05-12

Substantially Equivalent

Oxis Intl., Inc.

FDA 510(k) clearance K970510 for INNOFLOUR TOPIRAMATE REAGENT SET, Substantially Equivalent on 1997-05-12. Applicant: Oxis Intl., Inc.. Device class: 2.

Clearance details

Applicant: Oxis Intl., Inc.
Product code: Code MSL
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1997-02-11
Decision date: 1997-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, US

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