Cleared Traditional

CARDIOLIPIN IGG,M,A EIA TEST SYSTEM

K951363 · Immunoprobe, Inc. · Immunology
Oct 1995
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K951363 is an FDA 510(k) clearance for the CARDIOLIPIN IGG,M,A 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 October 13, 1995, 203 days after receiving the submission on March 24, 1995. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K951363 FDA.gov
FDA Decision Cleared SESE
Date Received March 24, 1995
Decision Date October 13, 1995
Days to Decision 203 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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