QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS— 510(k) K141210

Name: FDA 510(k) clearance K141210
Creator: U.S. Food and Drug Administration
Published: 2015-01-29

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K141210 for QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS, Substantially Equivalent on 2015-01-29. 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: 2014-05-09
Decision date: 2015-01-29
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.