Cleared Traditional

K951205 - VARELISA ANA PROFILE
(FDA 510(k) Clearance)

K951205 · Elias U.S.A., Inc. · Immunology

Apr 1995

Decision

31d

Days

Class 2

Risk

K951205 is an FDA 510(k) clearance for the VARELISA ANA PROFILE. This device is classified as a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM).

Submitted by Elias U.S.A., Inc. (Osceola, US). The FDA issued a Cleared decision on April 17, 1995, 31 days after receiving the submission on March 17, 1995.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K951205 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 17, 1995
Decision Date	April 17, 1995
Days to Decision	31 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement