Cleared Traditional

THERATEST EL-ANA PROFILES

K051066 · Theratest Laboratories, Inc. · Immunology
Oct 2005
Decision
164d
Days
Class 2
Risk

About This 510(k) Submission

K051066 is an FDA 510(k) clearance for the THERATEST EL-ANA PROFILES, a Anti-sm Antibody, Antigen And Control (Class II — Special Controls, product code LKP), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on October 7, 2005, 164 days after receiving the submission on April 26, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K051066 FDA.gov
FDA Decision Cleared SESE
Date Received April 26, 2005
Decision Date October 07, 2005
Days to Decision 164 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code LKP — Anti-sm Antibody, Antigen And Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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