Magellan Diagnostics, Inc.

FDA Device Registration & Listing · N Billerica, MA, US · Registration 1218996

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1218996
FEI Number
1218996
Entity Name
Magellan Diagnostics, Inc.
City/State/Country
N Billerica, MA, US
Establishment Address
101 Billerica Ave Bldg 4, N Billerica, MA 01862, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
MAGELLAN Diagnostics INC. (Owner Number: 1218996)
Owner / Operator Contact Address
101 Billerica Ave Bldg 4, --, N Billerica, MA 01862, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K123563
PMA Number
N/A

All Registered Proprietary Names

LeadCare II Blood Lead Testing Syst LeadCare Plus LeadCare Ultra

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DOF Lead, Atomic Absorption Clinical Toxicology Class 2 862.3550 2007-10-10
DOF Lead, Atomic Absorption Clinical Toxicology Class 2 862.3550 2015-11-11
DOF Lead, Atomic Absorption Clinical Toxicology Class 2 862.3550 2013-11-21

Official Correspondent

Vernon Brown

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

MAGELLAN Diagnostics INC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0042-2008 Esa Biosciences, Inc. 2
ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762
Z-0043-2008 Esa Biosciences, Inc. 2
ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1218996. Last updated year: 2026. Please use registration number 1218996 when referencing this establishment in official correspondence.
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