ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR— 510(k) K032458

Name: FDA 510(k) clearance K032458
Creator: U.S. Food and Drug Administration
Published: 2003-10-06

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K032458 for ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR, Substantially Equivalent on 2003-10-06. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Device name as filed: ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT
Applicant: Abbott Laboratories
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2003-08-11
Decision date: 2003-10-06
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JIT

view all

K171168 — VITROS Immunodiagnostic Products Insulin Calibrators2017-05-16
K170938 — CalSet IGF-12017-04-26
K170160 — Abbott ARCHITECT Free T32017-02-15
K163534 — Lumipulse G FSH-N Calibrators2017-01-13
K163546 — Lumipulse G Progesterone-N Calibrators2017-01-13

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.