ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS— 510(k) K102699

Name: FDA 510(k) clearance K102699
Creator: U.S. Food and Drug Administration
Published: 2011-04-01

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K102699 for ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS, Substantially Equivalent on 2011-04-01. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LCD
Device class: Class 2
Regulation: 21 CFR 862.3450
Advisory panel: Clinical Toxicology
Date received: 2010-09-20
Decision date: 2011-04-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, IL, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K102699

K-number listed on FDA's recall record

Z-2117-2020 — ARCHITECT iGentamicin Reagent Kit - Product Usage: The measurements obtained are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to help ensure appropriate therapy.Class II·Ongoing·Abbott Gmbh & Co. KG·20200424

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102699.

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