LCX CHLAMYDIA TRACHOMATIS ASSAY— 510(k) K934622

Name: FDA 510(k) clearance K934622
Creator: U.S. Food and Drug Administration
Published: 1995-12-08

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K934622 for LCX CHLAMYDIA TRACHOMATIS ASSAY, Substantially Equivalent on 1995-12-08. Applicant: Abbott Laboratories. Device class: 1.

Clearance details

Applicant: Abbott Laboratories
Product code: Code MKZ
Device class: Class 1
Regulation: 21 CFR 866.3120
Advisory panel: Microbiology
Date received: 1993-09-27
Decision date: 1995-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MKZ

view all

K230451 — Aptima® Chlamydia trachomatis Assay2023-11-16
K140446 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY2014-05-20
K110923 — COBAS 4800 CT / NG TEST2012-01-24
K091724 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY2009-11-13
K090824 — BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY2009-06-02

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

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