Cleared Traditional

CARDIOLIPIN IGG,M,A EIA TEST KIT

K952520 · Immunoprobe, Inc. · Immunology
Sep 1995
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K952520 is an FDA 510(k) clearance for the CARDIOLIPIN IGG,M,A EIA TEST KIT, 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 September 15, 1995, 106 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 K952520 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 1995
Decision Date September 15, 1995
Days to Decision 106 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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