QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS— 510(k) K141655

Name: FDA 510(k) clearance K141655
Creator: U.S. Food and Drug Administration
Published: 2015-03-05

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K141655 for QUANTA FLASH RO52, QUANTA FLASH RO52 CALIBRATORS, AND QUANTA FLASH RO52 CONTROLS, Substantially Equivalent on 2015-03-05. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code OBE
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2014-06-20
Decision date: 2015-03-05
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.