CENTRIA PHENYTOIN RIA TEST SET— 510(k) K791896

Name: FDA 510(k) clearance K791896
Creator: U.S. Food and Drug Administration
Published: 1979-10-17

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K791896 for CENTRIA PHENYTOIN RIA TEST SET, Substantially Equivalent on 1979-10-17. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code DLP
Device class: Class 2
Regulation: 21 CFR 862.3350
Advisory panel: Clinical Toxicology
Date received: 1979-09-25
Decision date: 1979-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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