Cleared Special

EL-ACL SCREEN; EL-ACL IGM, IGG, IGA

K060176 · Theratest Laboratories, Inc. · Immunology
Feb 2006
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K060176 is an FDA 510(k) clearance for the EL-ACL SCREEN; EL-ACL IGM, IGG, IGA, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on February 7, 2006, 15 days after receiving the submission on January 23, 2006. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K060176 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2006
Decision Date February 07, 2006
Days to Decision 15 days
Submission Type Special
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MID — System, Test, Anticardiolipin Immunological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5660

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