Cleared Traditional

EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P

K024151 · Theratest Laboratories, Inc. · Immunology
Feb 2003
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K024151 is an FDA 510(k) clearance for the EL-ANA PROFILES: ANTI-RIBOSOMAL PROTEIN P, a Anti-ribosomal P Antibodies (Class II — Special Controls, product code MQA), submitted by Theratest Laboratories, Inc. (Lombard, US). The FDA issued a Cleared decision on February 6, 2003, 62 days after receiving the submission on December 6, 2002. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K024151 FDA.gov
FDA Decision Cleared SESE
Date Received December 06, 2002
Decision Date February 06, 2003
Days to Decision 62 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MQA — Anti-ribosomal P Antibodies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100