Cleared Traditional

CARDIOLIPIN IGM EIA TEST SYSTEM

K952521 · Immunoprobe, Inc. · Immunology
Feb 1996
Decision
253d
Days
Class 2
Risk

About This 510(k) Submission

K952521 is an FDA 510(k) clearance for the CARDIOLIPIN IGM EIA TEST SYSTEM, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Immunoprobe, Inc. (Washington, US). The FDA issued a Cleared decision on February 9, 1996, 253 days after receiving the submission on June 1, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K952521 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1995
Decision Date February 09, 1996
Days to Decision 253 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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