AUTOSTAT II RHEUMATOID FACTOR IGA ELISA— 510(k) K993557

Name: FDA 510(k) clearance K993557
Creator: U.S. Food and Drug Administration
Published: 2000-03-03

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K993557 for AUTOSTAT II RHEUMATOID FACTOR IGA ELISA, Substantially Equivalent on 2000-03-03. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1999-10-20
Decision date: 2000-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, Scotland, GB

Download summary PDF View on FDA.gov ↗

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