VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM— 510(k) K890610

Name: FDA 510(k) clearance K890610
Creator: U.S. Food and Drug Administration
Published: 1989-06-23

Substantially Equivalent

Organon Teknika Corp.

FDA 510(k) clearance K890610 for VIRONOSTIKA(TM) ANTI-CMV IGM MICROELISA SYSTEM, Substantially Equivalent on 1989-06-23. Applicant: Organon Teknika Corp.. Device class: 2.

Clearance details

Applicant: Organon Teknika Corp.
Product code: Code LFZ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1989-02-07
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Durham, NC, 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 Organon Teknika Corp.

view all

K003104 — BACT/ALERT CSR2000-10-20
K000492 — MDA D-DIMER2000-06-07
K000378 — BACT/ALERT MB CULTURE BOTTLE2000-03-02
K994343 — BACT/ALERT SV2000-02-10
K993423 — BACT/ALERT SA1999-12-15

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