QUANTA PLEX ENA PROFILE 5— 510(k) K030681

Name: FDA 510(k) clearance K030681
Creator: U.S. Food and Drug Administration
Published: 2003-04-24

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K030681 for QUANTA PLEX ENA PROFILE 5, Substantially Equivalent on 2003-04-24. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2003-03-05
Decision date: 2003-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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.