AUTOSTATTMII ANTI-DSDNA— 510(k) K952567

Name: FDA 510(k) clearance K952567
Creator: U.S. Food and Drug Administration
Published: 1997-03-04

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K952567 for AUTOSTATTMII ANTI-DSDNA, Substantially Equivalent on 1997-03-04. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code LRM
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 1995-06-05
Decision date: 1997-03-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code LRM

view all

K101319 — IMMULISA DSDNA ANTIBODY ELISA2010-12-09
K083381 — EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG)2009-04-15
K062183 — FARRZYME HUMAN HIGH AVIDITY ANTI-DSDNA ENZYME IMMUNOASSAY KIT2006-11-21
K040811 — VARELISA SSDNA ANTIBODIES, MODEL 148962004-05-13
K001900 — ENZYME IMMUNOASSAY ANTI-SSDNA ANTIBODY TEST2000-09-11

More clearances from Cogent Diagnotics , Ltd.

view all

K003054 — AUTOSTAT II ENA-6 PROFILE ELISA2000-10-13
K003057 — AUTOSTAT II ENA-4 PROFILE ELISA2000-10-13
K002215 — AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA2000-09-28
K993557 — AUTOSTAT II RHEUMATOID FACTOR IGA ELISA2000-03-03
K994338 — AUTOSTAT II RHEUMATOID FACTOR IGM ELISA2000-02-03

Data sourced from openFDA. This site is unofficial and independent of the FDA.