ClearanceBrief
Company ยท US

Magellan Diagnostics, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2015. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)
17recalls (5 in 12 months)
17recalls that name a 510(k)

Product codes

CodeDeviceRecords
DOFLead, Atomic Absorption19

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Jul 7, 2015K142705LeadCare Plus Blood Lead Testing System
Magellan Diagnostics
DOF
Aug 20, 2013K123563LEADCARE (R) ULTRA (TM) BLOOD LEAD TESTING SYSTEM
Magellan Diagnostics
DOF

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 15, 2026Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit. Model/Catalog Number: 70-6762.
Open, Classified		 DOFK052549
Apr 17, 2026Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit; Catalog Number: 70-8098; The LeadCare Ultra kit is provided with the following materials: " Sensors (8 containers of 24 each; 192 tests) " Treatment Reagent Tubes
Open, Classified		 DOFK052549
Apr 17, 2026Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit; Catalog Number: 82-0004; The LeadCare Plus kit is provided with the following materials: " Sensors (4 containers of 24 each; 96 tests) " Treatment Reagent Tubes (4
Open, Classified		 DOFK142705
Apr 17, 2026Magellan Diagnostics, Inc.
(1)(2) LeadCare II Blood Lead Test Kit, (3)LeadCare II 5X Blood Lead Test Kit, (4)LeadCare II 9X Blood Lead Test Kit ; Catalog Number(s): (1) 70-6762, (2) 70-6762RUO, (3) 70-8404 (Box containing 5 Tes
Open, Classified		 DOFK052549
Nov 21, 2025Magellan Diagnostics, Inc.
The LeadCare II Blood Lead Test System relies on electrochemistry and a unique Sensor to detect lead in whole blood. The LeadCare II Test Kit is provided with the following materials: " Sensors (2 Co
Open, Classified		 DOFK052549
Nov 3, 2023Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit-For in vitro diagnostic use only. The test kit is for the quantitative measurement of lead in capillary whole blood.
Open, Classified		 DOFK052549
Jul 1, 2021Magellan Diagnostics, Inc.
LeadCare Ultra Blood Lead Test Kit Catalog Number 70-8098
Terminated		 DOFK123563
Jul 1, 2021Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Test Kit Catalog Number 82-0004
Terminated		 DOFK142705
Jul 1, 2021Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit Catalog Number 70-6762
Terminated		 DOFK052549
Aug 8, 2018Magellan Diagnostics, Inc.
Magellan LeadCare II Blood Lead Test Kit. In Vitro Test for the measurement of lead in fresh whole blood. Catalog Number: 70-6762 Primary DI No: 00850355006000 The LeadCare II Blood Lead Test Kit is
Terminated		 DOFK052549
K971640
Jan 9, 2018Magellan Diagnostics, Inc.
LeadCare Plus Blood Lead Analyzer Part Number: 82-0001 Intended for the quantitative measurement of lead in a whole blood sample.
Terminated		 DOFK142705
Jan 9, 2018Magellan Diagnostics, Inc.
LeadCare II Blood Lead Analyzer Part Numbers: 70-6760, 70-6529-R, 70-6760-P, 70-6760-R. Intended for in vitro (external) use only.
Terminated		 DOFK052549
Aug 15, 2017Magellan Diagnostics, Inc.
LeadCare II Blood Lead Test Kit, containing LeadCare II Lead Controls Product Usage: IVD test kit for the detection of lead in blood. The kit consists of sensors, treatment reagent, lead controls
Terminated		 DOFK052549
Jun 5, 2017Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra and LeadCare Plus test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measureme
Terminated		 DOFK052549
Jun 5, 2017Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare and LeadCare II test Kits. Product Usage: The LeadCare Blood Lead Test Kit is for in vitro diagnostic use only. The Test Kit is for the quantitative measurement of l
Terminated		 DOFK971640
May 18, 2017Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Lead Test Kits Part Number: 80-0010
Terminated		 DOFK142705
May 18, 2017Magellan Diagnostics, Inc.
Magellan Diagnostics LeadCare Ultra Blood Analyzer Part Number: 80-0010
Terminated		 DOFK123563
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