IS ANTI-TPO IGG ELISA TEST SYSTEM— 510(k) K984228

Name: FDA 510(k) clearance K984228
Creator: U.S. Food and Drug Administration
Published: 1999-02-02

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K984228 for IS ANTI-TPO IGG ELISA TEST SYSTEM, Substantially Equivalent on 1999-02-02. Applicant: Columbia Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1998-11-25
Decision date: 1999-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZO

view all

K250250 — ADVIA Centaur Anti-Thyroid Peroxidase II2025-10-17
K240469 — Access TPO Antibody2024-08-09
K213517 — Access Thyroglobulin Antibody II2023-09-26
K222610 — Elecsys Anti-Tg2023-09-15
K193313 — Elecsys Anti-TSHR2020-02-27

More clearances from Columbia Bioscience, Inc.

view all

K990462 — IS H. PYLORI IGG ELISA TEST SYSTEM1999-09-03
K991274 — MUMPS IGG ELISA TEST SYSTEM1999-09-03
K983605 — IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM1998-12-16
K983606 — IS BORRELIA BURGDORFERI IGM TEST SYSTEM1998-12-16
K983553 — ANTI-TG IGG ELISA TEST SYSTEM1998-12-07

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