Cleared Traditional

RIBOSOMAL P EIA TEST SYSTEM

K950169 · Hogan & Hartson · Immunology
May 1996
Decision
492d
Days
Class 2
Risk

About This 510(k) Submission

K950169 is an FDA 510(k) clearance for the RIBOSOMAL P EIA TEST SYSTEM, a Anti-ribosomal P Antibodies (Class II — Special Controls, product code MQA), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on May 23, 1996, 492 days after receiving the submission on January 17, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K950169 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 1995
Decision Date May 23, 1996
Days to Decision 492 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

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