VENTREZYME T4U IMMUNOASSAY T4U— 510(k) K841024

Name: FDA 510(k) clearance K841024
Creator: U.S. Food and Drug Administration
Published: 1984-05-09

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K841024 for VENTREZYME T4U IMMUNOASSAY T4U, Substantially Equivalent on 1984-05-09. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code CEE
Device class: Class 2
Regulation: 21 CFR 862.1685
Advisory panel: Clinical Chemistry
Date received: 1984-03-12
Decision date: 1984-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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