Cleared Traditional

CARDIOLIPIN G EIA TEST SYSTEM

K946215 · Hogan & Hartson · Immunology
Jan 1996
Decision
399d
Days
Class 2
Risk

About This 510(k) Submission

K946215 is an FDA 510(k) clearance for the CARDIOLIPIN G EIA TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Hogan & Hartson (Washington, US). The FDA issued a Cleared decision on January 24, 1996, 399 days after receiving the submission on December 21, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K946215 FDA.gov
FDA Decision Cleared SESE
Date Received December 21, 1994
Decision Date January 24, 1996
Days to Decision 399 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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