ABBOTT CMV-M EIA KIT— 510(k) K872881

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K872881 for ABBOTT CMV-M EIA KIT, Substantially Equivalent on 1988-05-13. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LKQ
Device class: Class 2
Regulation: 21 CFR 866.3175
Advisory panel: Microbiology
Date received: 1987-07-22
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LKQ

K100433 — IMMULITE 2000 CMV IGM, IMMULITE CMV IGM CONTROLS, AND IMMULITE 200 CMV IGM ADJUSTOR MODEL L2KCM2, L2KCM6, LCMC1, LCMC2,2010-05-13
K972884 — ACCURUN 146 CMV IGM POSITIVE CONTROL1997-08-22
K933549 — VIDAS CMV IGM ASSAY1994-08-02
K922580 — BARTELS CYTOMEGALOVIRUS IGM EIA1993-04-08
K914789 — ELISA CMV IGM1992-03-04

More clearances from Abbott Laboratories

K252424 — Anti-HCV Next2026-04-28
K243500 — ARCHITECT iGentamicin2025-07-09
K243168 — Alinity i Rubella IgG2025-06-20
K243283 — Alinity h-series System2025-02-20
K233932 — Alinity i Toxo IgM2024-08-30

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