QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls— 510(k) K163538

Name: FDA 510(k) clearance K163538
Creator: U.S. Food and Drug Administration
Published: 2017-09-06

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K163538 for QUANTA Flash® LKM-1 Reagents, QUANTA Flash® LKM-1 Calibrators, QUANTA Flash® LKM-1 Controls, Substantially Equivalent on 2017-09-06. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code NBS
Device class: Class 2
Regulation: 21 CFR 866.5660
Advisory panel: Immunology
Date received: 2016-12-16
Decision date: 2017-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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