QUANTA FLASH ENA7— 510(k) K122923

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K122923 for QUANTA FLASH ENA7, Substantially Equivalent on 2013-05-07. 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: 2012-09-24
Decision date: 2013-05-07
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.