LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM— 510(k) K123563

Name: FDA 510(k) clearance K123563
Creator: U.S. Food and Drug Administration
Published: 2013-08-20

Substantially Equivalent

Magellan Diagnostics

FDA 510(k) clearance K123563 for LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM, Substantially Equivalent on 2013-08-20. Applicant: Magellan Diagnostics. Device class: 2.

Clearance details

Applicant: Magellan Diagnostics
Product code: Code DOF
Device class: Class 2
Regulation: 21 CFR 862.3550
Advisory panel: Clinical Toxicology
Date received: 2012-11-19
Decision date: 2013-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: N. Billerica, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DOF

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K142705 — LeadCare Plus Blood Lead Testing System2015-07-07
K052549 — LEADCARE II BLOOD LEAD TESTING SYSTEM2005-10-06
K971640 — LEADCARE BLOOD LEAD TESTING SYSTEM1997-09-09
K936060 — ATOMSPEC GF BLOOD LEAD WORKSTATION1994-09-06
K843839 — STAT/PB REAGENT1985-01-03

Recalls naming K123563

K-number listed on FDA's recall record

Z-1954-2021 — LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098Class I·Terminated·Magellan Diagnostics, Inc.·20210507
Z-1925-2017 — Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010Class I·Terminated·Magellan Diagnostics, Inc.·20141129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K123563.

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