AUTOSTAT II ANTI-TPO— 510(k) K943580

Substantially Equivalent

Cogent Diagnotics , Ltd.

FDA 510(k) clearance K943580 for AUTOSTAT II ANTI-TPO, Substantially Equivalent on 1995-04-17. Applicant: Cogent Diagnotics , Ltd.. Device class: 2.

Clearance details

Applicant: Cogent Diagnotics , Ltd.
Product code: Code JNL
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1994-07-22
Decision date: 1995-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edinburgh, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code JNL

K250816 — ADVIA Centaur Anti-Thyroglobulin II (aTgII)2025-12-04
K240996 — Access Thyroglobulin Antibody II2024-07-03
K112933 — ACCESS THYROGLOBULIN ANITBODY2011-12-27
K072661 — IMMUNOCAP THYRLOBULIN IMMUNOCAP2007-11-20
K062516 — ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)2006-10-05

More clearances from Cogent Diagnotics , Ltd.

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.