Cleared Traditional

ELIA SCL-70S IMMUNOASSAY

K140493 · Phadia GmbH · Immunology

Oct 2014

Decision

245d

Days

Class 2

Risk

About This 510(k) Submission

K140493 is an FDA 510(k) clearance for the ELIA SCL-70S IMMUNOASSAY, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Phadia GmbH (Portae, US). The FDA issued a Cleared decision on October 30, 2014, 245 days after receiving the submission on February 27, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K140493 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2014
Decision Date	October 30, 2014
Days to Decision	245 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF