NOVA LITE TM THYROID— 510(k) K904224

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K904224 for NOVA LITE TM THYROID, Substantially Equivalent on 1990-10-15. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code JZO
Device class: Class 2
Regulation: 21 CFR 866.5870
Advisory panel: Immunology
Date received: 1990-09-13
Decision date: 1990-10-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JZO

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 Inova Diagnostics, Inc.

K243979 — Aptiva APS IgA Reagent2026-02-06
K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent2024-12-17
K213403 — Aptiva CTD Essential Reagent2023-09-29
K200230 — Aptiva Celiac Disease IgG Reagent2021-08-26
K193604 — Aptiva Celiac Disease IgA Reagent2021-06-16

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