CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV— 510(k) K820298

Name: FDA 510(k) clearance K820298
Creator: U.S. Food and Drug Administration
Published: 1982-04-08

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K820298 for CARCINOEMBRYONIC ANTIGEN CONTROL (4 LEV, Substantially Equivalent on 1982-04-08. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code DHX
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 1982-02-04
Decision date: 1982-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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