TURBO-RAST SPECIFIC IGE ASSAY— 510(k) K903000

Name: FDA 510(k) clearance K903000
Creator: U.S. Food and Drug Administration
Published: 1990-07-31

Substantially Equivalent

Ventrex Laboratories, Inc.

FDA 510(k) clearance K903000 for TURBO-RAST SPECIFIC IGE ASSAY, Substantially Equivalent on 1990-07-31. Applicant: Ventrex Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Ventrex Laboratories, Inc.
Product code: Code JHR
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 1990-07-09
Decision date: 1990-07-31
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.