Cleared Traditional

AUTOSTAT II ANTI-GLIADIN IGA ELISA

K993086 · Cogent Diagnotics , Ltd. · Immunology
Nov 1999
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K993086 is an FDA 510(k) clearance for the AUTOSTAT II ANTI-GLIADIN IGA ELISA, a Antibodies, Gliadin (Class II — Special Controls, product code MST), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on November 12, 1999, 58 days after receiving the submission on September 15, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5750.

Submission Details

510(k) Number K993086 FDA.gov
FDA Decision Cleared SESE
Date Received September 15, 1999
Decision Date November 12, 1999
Days to Decision 58 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code MST — Antibodies, Gliadin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5750

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