VIDAS CMV IGG ASSAY— 510(k) K920661

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K920661 for VIDAS CMV IGG ASSAY, Substantially Equivalent on 1993-02-12. Applicant: Vitek Systems, Inc.. Device class: 2.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1992-02-13
Decision date: 1993-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFZ

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 Vitek Systems, Inc.

K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-07-28
K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-04-08
K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY1992-04-07
K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION1992-03-04
K905211 — VIDAS CLOSTRIDIUM DIFFICILE TOXIN A (CDA) ASSAY1991-10-11

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