Cleared Traditional

SYNELISA ANA TOTAL

K935468 · Elias U.S.A., Inc. · Immunology
Mar 1994
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K935468 is an FDA 510(k) clearance for the SYNELISA ANA TOTAL, 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 March 25, 1994, 133 days after receiving the submission on November 12, 1993. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K935468 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1993
Decision Date March 25, 1994
Days to Decision 133 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LJM — Antinuclear Antibody (enzyme-labeled), Antigen, Controls
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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