QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols— 510(k) K151429

Name: FDA 510(k) clearance K151429
Creator: U.S. Food and Drug Administration
Published: 2016-02-12

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K151429 for QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols, Substantially Equivalent on 2016-02-12. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LLL
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2015-05-28
Decision date: 2016-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLL

view all

K253817 — IDS SS-A/Ro; IDS SS-A/Ro 60 kDa; IDS SS-B/La2026-08-21
K253367 — EliA CTD 13 Screen2026-06-25
K250666 — Alegria Flash CTD Screen2025-10-22
K250408 — Alegria Flash ENA Screen2025-09-19
K213403 — Aptiva CTD Essential Reagent2023-09-29

More clearances from Inova Diagnostics, Inc.

view all

K243979 — Aptiva APS IgA Reagent2026-02-06
K223093 — Aptiva APS IgG Reagent; Aptiva APS IgM Reagent2024-12-17
K200230 — Aptiva Celiac Disease IgG Reagent2021-08-26
K193604 — Aptiva Celiac Disease IgA Reagent2021-06-16
K192916 — NOVA Lite DAPI dsDNA Crithidia luciliae Kit2020-12-11

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