QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer— 510(k) K170993

Name: FDA 510(k) clearance K170993
Creator: U.S. Food and Drug Administration
Published: 2017-12-22

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K170993 for QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer, Substantially Equivalent on 2017-12-22. 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: 2017-04-03
Decision date: 2017-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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