CYTOMEGALOVIRUS IGG EIA KIT— 510(k) K880433

Name: FDA 510(k) clearance K880433
Creator: U.S. Food and Drug Administration
Published: 1989-03-27

Substantially Equivalent

De Ferris Laboratories, Inc.

FDA 510(k) clearance K880433 for CYTOMEGALOVIRUS IGG EIA KIT, Substantially Equivalent on 1989-03-27. Applicant: De Ferris Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: De Ferris Laboratories, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1988-02-01
Decision date: 1989-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, 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 De Ferris Laboratories, Inc.

view all

K875258 — TOXOPLASMA GONDII IGG ELISA KIT1988-09-30

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