VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC— 510(k) K843230

Name: FDA 510(k) clearance K843230
Creator: U.S. Food and Drug Administration
Published: 1984-09-04

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K843230 for VENTREZYME PAP KIT IMMUNOASSAY PROSTATIC, Substantially Equivalent on 1984-09-04. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code JFH
Device class: Class 2
Regulation: 21 CFR 862.1020
Advisory panel: Clinical Chemistry
Date received: 1984-08-17
Decision date: 1984-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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