Cleared Traditional

AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA

K992440 · Cogent Diagnotics , Ltd. · Immunology
Sep 1999
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K992440 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA, a System, Test, Anticardiolipin Immunological (Class II — Special Controls, product code MID), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on September 21, 1999, 61 days after receiving the submission on July 22, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number K992440 FDA.gov
FDA Decision Cleared SESE
Date Received July 22, 1999
Decision Date September 21, 1999
Days to Decision 61 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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