QUANTA LITE PBC SCREEN IGG/IGA ELISA— 510(k) K061842

Name: FDA 510(k) clearance K061842
Creator: U.S. Food and Drug Administration
Published: 2006-10-18

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K061842 for QUANTA LITE PBC SCREEN IGG/IGA ELISA, Substantially Equivalent on 2006-10-18. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NRI
Device class: Class 2
Regulation: 21 CFR 866.5090
Advisory panel: Immunology
Date received: 2006-06-29
Decision date: 2006-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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