ABBOTT ARCHITECT FERRITIN— 510(k) K983759

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K983759 for ABBOTT ARCHITECT FERRITIN, Substantially Equivalent on 1998-12-07. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code DBF
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1998-10-26
Decision date: 1998-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K983759

K-number listed on FDA's recall record

Z-2208-2019 — Alinity i Ferritin Reagent Kit, List Number 07P6530 The Alinity i Ferritin assay is a chemiluminescent microparticle immunoassay (CMIA) used for the quantitative determination of ferritin in human serum and plasma on the Alinity i analyzer.Class II·Terminated·Abbott Ireland Diagnostics Division·20181121

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983759.

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