DeviceClearance

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

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..

Clearance details

Applicant
Inova Diagnostics, Inc.
Product code
Code NBS
Advisory panel
Immunology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
San Diego, CA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.