QUANTA Flash Calprotectin and Fecal Extraction Device— 510(k) K180971

Name: FDA 510(k) clearance K180971
Creator: U.S. Food and Drug Administration
Published: 2018-10-16

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K180971 for QUANTA Flash Calprotectin and Fecal Extraction Device, Substantially Equivalent on 2018-10-16. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NXO
Device class: Class 2
Regulation: 21 CFR 866.5180
Advisory panel: Immunology
Date received: 2018-04-13
Decision date: 2018-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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