QUANTA LITE CMV IGG ELISA— 510(k) K971335

Name: FDA 510(k) clearance K971335
Creator: U.S. Food and Drug Administration
Published: 1997-12-01

Substantially Equivalent

Inova Diagnostics, Inc.

FDA 510(k) clearance K971335 for QUANTA LITE CMV IGG ELISA, Substantially Equivalent on 1997-12-01. Applicant: Inova Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Inova Diagnostics, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1997-04-10
Decision date: 1997-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

view all

K220949 — Architect CMV IgG2022-10-27
K220911 — Elecsys CMV IgG2022-10-12
K181213 — ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control2018-07-30
K163569 — Elecsys CMV IgM2017-03-17
K162969 — LIAISON® CMV IgG and LIAISON® CMV IgG Serum Control Set2017-01-06

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
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.