VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY— 510(k) K880547

Name: FDA 510(k) clearance K880547
Creator: U.S. Food and Drug Administration
Published: 1988-03-25

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K880547 for VENTREZYME VAST IMMUNO-PEROXIDASE ASSAY, Substantially Equivalent on 1988-03-25. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code DHB
Device class: Class 2
Regulation: 21 CFR 866.5750
Advisory panel: Immunology
Date received: 1988-02-09
Decision date: 1988-03-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.