QUANTA FLASH CENTROMERE— 510(k) K123880

Name: FDA 510(k) clearance K123880
Creator: U.S. Food and Drug Administration
Published: 2014-02-07

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K123880 for QUANTA FLASH CENTROMERE, Substantially Equivalent on 2014-02-07. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LJM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2012-12-17
Decision date: 2014-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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