Cleared Traditional

AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

K994338 · Cogent Diagnotics , Ltd. · Immunology
Feb 2000
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K994338 is an FDA 510(k) clearance for the AUTOSTAT II RHEUMATOID FACTOR IGM ELISA, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by Cogent Diagnotics , Ltd. (Midlothian, Scotland, GB). The FDA issued a Cleared decision on February 3, 2000, 42 days after receiving the submission on December 23, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K994338 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1999
Decision Date February 03, 2000
Days to Decision 42 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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