CYBREX TM FPQ FLUORESCENE POLARIZATION— 510(k) K802579

Name: FDA 510(k) clearance K802579
Creator: U.S. Food and Drug Administration
Published: 1980-11-12

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K802579 for CYBREX TM FPQ FLUORESCENE POLARIZATION, Substantially Equivalent on 1980-11-12. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code KHO
Device class: Class 1
Regulation: 21 CFR 862.2560
Advisory panel: Clinical Chemistry
Date received: 1980-10-20
Decision date: 1980-11-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KHO

view all

K112161 — AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE..2012-01-20
K973547 — TRIAGE STATMETER1998-01-13
K971103 — AIA NEXIA-AUTOMATED ENZYME IMMUNOASSAY SYSTEM1997-06-27
K962919 — VITROS IMMUNODIAGNOSTIC SYSTEM1996-10-18
K952719 — BIOCIRCUITS IOS (IN-OFFICE SYSTEM)1995-11-22

More clearances from Abbott Laboratories

view all

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

Adverse events under product code KHO

product code KHO

Malfunction: 1,339
Total: 1,339

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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