VENTREZYME ALLERGEN DATA REDUCTION SYSTEM— 510(k) K851403

Name: FDA 510(k) clearance K851403
Creator: U.S. Food and Drug Administration
Published: 1985-06-21

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K851403 for VENTREZYME ALLERGEN DATA REDUCTION SYSTEM, Substantially Equivalent on 1985-06-21. Applicant: Ventrex Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code JQW
Device class: Class 1
Regulation: 21 CFR 862.2750
Advisory panel: Clinical Chemistry
Date received: 1985-04-09
Decision date: 1985-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, ME, US

Download summary PDF View on FDA.gov ↗

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